Trial Outcomes & Findings for Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars (NCT NCT04115358)
NCT ID: NCT04115358
Last Updated: 2021-08-03
Results Overview
Sensitivity to biting, chewing and clinically to the percussion by a probe
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Change from Baseline at 1 month in 3 groups
Results posted on
2021-08-03
Participant Flow
The first participant was enrolled in May 2019 and the last participant was enrolled in September 2019. No important changes in methods or selection criteria have been done. 1st, 3rd and 6th months assessments were made without complications but 1-year examination had some face to face problems with the Covid-19 pandemics. So some final examinations and patient comforts had been done via phone and/or online connections.
The study was initially carried out on 136 primary molars of 47 children. Three children (2 boys, 1 girl) did not show up in any recalls, so the study was performed in 130 primary molars.
Unit of analysis: teeth
Participant milestones
| Measure |
Hyaluronic Acid
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.
|
Formocresol
0,1 ml to the orifice of the root canals of the primary molar.
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.
|
Ferric Sulfate
0,1 ml to the orifice of the root canals of the primary molar.
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.
|
|---|---|---|---|
|
Overall Study
STARTED
|
34 51
|
33 40
|
34 39
|
|
Overall Study
COMPLETED
|
34 48
|
33 40
|
33 38
|
|
Overall Study
NOT COMPLETED
|
0 3
|
0 0
|
1 1
|
Reasons for withdrawal
| Measure |
Hyaluronic Acid
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.
|
Formocresol
0,1 ml to the orifice of the root canals of the primary molar.
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.
|
Ferric Sulfate
0,1 ml to the orifice of the root canals of the primary molar.
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.
|
|---|---|---|---|
|
Overall Study
exfoliation
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hyaluronic Acid
n=51 tooth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar.
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material.
|
Formocresol
n=40 tooth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material.
|
Ferric Sulfate
n=39 tooth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material.
|
Total
n=130 tooth
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
34 Participants
n=34 Participants
|
33 Participants
n=33 Participants
|
34 Participants
n=34 Participants
|
101 Participants
n=101 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=101 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=101 Participants
|
|
Age, Continuous
|
6.65 years
STANDARD_DEVIATION 0.99 • n=34 Participants
|
6.83 years
STANDARD_DEVIATION 0.98 • n=33 Participants
|
6.67 years
STANDARD_DEVIATION 1.08 • n=34 Participants
|
6.71 years
STANDARD_DEVIATION 1.015 • n=101 Participants
|
|
Sex: Female, Male
Female
|
32 tooth
n=51 tooth
|
25 tooth
n=40 tooth
|
23 tooth
n=39 tooth
|
80 tooth
n=130 tooth
|
|
Sex: Female, Male
Male
|
19 tooth
n=51 tooth
|
15 tooth
n=40 tooth
|
16 tooth
n=39 tooth
|
50 tooth
n=130 tooth
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
34 Participants
n=34 Participants
|
33 Participants
n=33 Participants
|
34 Participants
n=34 Participants
|
101 Participants
n=101 Participants
|
|
Dental Arch/Tooth Type
Maxillary 1st primary molars
|
11 tooth
n=51 tooth
|
9 tooth
n=40 tooth
|
7 tooth
n=39 tooth
|
27 tooth
n=130 tooth
|
|
Dental Arch/Tooth Type
Maxillary 2nd primary molars
|
17 tooth
n=51 tooth
|
13 tooth
n=40 tooth
|
8 tooth
n=39 tooth
|
38 tooth
n=130 tooth
|
|
Dental Arch/Tooth Type
Mandibular 1st primary molars
|
14 tooth
n=51 tooth
|
11 tooth
n=40 tooth
|
15 tooth
n=39 tooth
|
40 tooth
n=130 tooth
|
|
Dental Arch/Tooth Type
Mandibular 2nd primary molars
|
9 tooth
n=51 tooth
|
7 tooth
n=40 tooth
|
9 tooth
n=39 tooth
|
25 tooth
n=130 tooth
|
|
Dental Arch
Lower Arch
|
23 tooth
n=51 tooth
|
18 tooth
n=40 tooth
|
24 tooth
n=39 tooth
|
65 tooth
n=130 tooth
|
|
Dental Arch
Upper Arch
|
28 tooth
n=51 tooth
|
22 tooth
n=40 tooth
|
15 tooth
n=39 tooth
|
65 tooth
n=130 tooth
|
|
Tooth Type
1st primary molars
|
25 tooth
n=51 tooth
|
20 tooth
n=40 tooth
|
22 tooth
n=39 tooth
|
67 tooth
n=130 tooth
|
|
Tooth Type
2nd primary molars
|
26 tooth
n=51 tooth
|
20 tooth
n=40 tooth
|
17 tooth
n=39 tooth
|
63 tooth
n=130 tooth
|
|
Final Restoration
SSC
|
33 tooth
n=51 tooth
|
28 tooth
n=40 tooth
|
28 tooth
n=39 tooth
|
89 tooth
n=130 tooth
|
|
Final Restoration
Composite
|
18 tooth
n=51 tooth
|
12 tooth
n=40 tooth
|
11 tooth
n=39 tooth
|
41 tooth
n=130 tooth
|
PRIMARY outcome
Timeframe: Change from Baseline at 1 month in 3 groupsSensitivity to biting, chewing and clinically to the percussion by a probe
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth Sensitive to Percussion in 3 Groups
|
7 teeth
|
6 teeth
|
3 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 3 months in 3 groupsPopulation: 1 tooth is extracted in HA group so 50 teeth are evaluated
Sensitivity to biting, chewing and clinically to the percussion by a probe
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth Sensitive to Percussion in 3 Groups
|
10 teeth
|
8 teeth
|
3 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 months in 3 groupsPopulation: 1 tooth exfoliated in FS group and 1 participant so no observation for 1 tooth and 1 participant in FS
Sensitivity to biting, chewing and clinically to the percussion by a probe
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth Sensitive to Percussion in 3 Groups
|
11 teeth
|
8 teeth
|
3 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 12 months in 3 groupsPopulation: 2 teeth exfoliated from HA group (not participants) so number of teeth reduced from 50 to 48
Sensitivity to biting, chewing and clinically to the percussion by a probe
Outcome measures
| Measure |
Hyaluronic Acid
n=48 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth Sensitive to Percussion in 3 Groups
|
2 teeth
|
6 teeth
|
2 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 1 month in 3 groupsMobility of the treated tooth and/or the tooth is sensitive to the vibration
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Mobile Teeth in 3 Groups
|
1 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 3 month in 3 groupsPopulation: 1 tooth extracted from HA group
Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Mobile Teeth in 3 Groups
|
1 teeth
|
0 teeth
|
1 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 month in 3 groupsPopulation: 1 tooth exfoliated from FS group (1 participant ) so 1 child and 1 tooth is reduced from FS group
Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Mobile Teeth in 3 Groups
|
3 teeth
|
2 teeth
|
1 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 12 months in 3 groupsPopulation: 2 teeth exfoliated from HA group (not participants) so 50 teeth reduced to 48 teeth but participants still exist
Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Outcome measures
| Measure |
Hyaluronic Acid
n=48 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Mobile Teeth in 3 Groups
|
4 teeth
|
4 teeth
|
3 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 1 month in 3 groupsAny pain history at that time frame and/or complaint of discomfort and pain clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
|
1 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 3 months in 3 groupsPopulation: 1 tooth extracted from HA group
Any pain history at that time frame and/or complaint of discomfort and pain clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 months in 3 groupsPopulation: 1 tooth exfoliated (one participant) so 1 tooth and 1 participant are reduced from FS group
Any pain history at that time frame and/or complaint of discomfort and pain clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 12 months in 3 groupsPopulation: 2 teeth exfoliated in HA group so 50 teeth reduced to 48 but no participant is reduced
Any pain history at that time frame and/or complaint of discomfort and pain clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=34 Participants
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=33 Participants
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=33 Participants
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 1 month in 3 groupsAny sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Dental Abscess in 3 Groups
|
1 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 3 months in 3 groupsAny sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Dental Abscess in 3 Groups
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 months in 3 groupsPopulation: 1 tooth exfoliated in FS group so 1 tooth and 1 participant are reduced in FS group
Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Dental Abscess in 3 Groups
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 12 monthsPopulation: 2 teeth exfoliated from HA group so number of teeth reduced from 50 to 48 but participants are same
Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Outcome measures
| Measure |
Hyaluronic Acid
n=48 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Dental Abscess in 3 Groups
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 1 month in 3 groupsThe tooth is missing or ready to exfoliate physiologically and no pathology is examined
Outcome measures
| Measure |
Hyaluronic Acid
n=34 Participants
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=33 Participants
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
|
0 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 3 months in 3 groupsThe tooth is missing or ready to exfoliate physiologically and no pathology is examined
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
|
1 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 months in 3 groupsThe tooth is missing or ready to exfoliate physiologically and no pathology is examined
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
|
0 teeth
|
0 teeth
|
1 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 12 months in 3 groupsPopulation: 2 exfoliations in HA group are shown here
The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
|
2 teeth
|
0 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 1 month in 3 groupsInternal, external, early or physiological root resorption from periapical/panoramic radiographs
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Root Resorption in 3 Groups
Periapical resorption
|
1 teeth
|
1 teeth
|
2 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
Internal resorption
|
6 teeth
|
4 teeth
|
1 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
External resorption
|
1 teeth
|
0 teeth
|
1 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
No resorption
|
43 teeth
|
35 teeth
|
35 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 3 months in 3 groupsPopulation: 1 tooth extracted in HA group
Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Root Resorption in 3 Groups
Periapical resorption
|
2 teeth
|
3 teeth
|
4 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
Internal resorption
|
9 teeth
|
11 teeth
|
6 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
External resorption
|
6 teeth
|
1 teeth
|
3 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
No resorption
|
33 teeth
|
25 teeth
|
26 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 monthsPopulation: 1 tooth exfoliated from FS group so 1 tooth and 1 participant reduced in FS group
Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Root Resorption in 3 Groups
Periapical resorption
|
7 teeth
|
5 teeth
|
5 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
Internal resorption
|
11 teeth
|
12 teeth
|
10 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
External resorption
|
5 teeth
|
5 teeth
|
5 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
No resorption
|
27 teeth
|
18 teeth
|
18 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 12 monthsPopulation: 6 participants, 12 teeth missing for xrays, 2 exfoliations from HA group; 7 participants, 8 teeth missing for xrays from FC group; 7 participants, 7 teeth missing for xrays from FS group
Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Outcome measures
| Measure |
Hyaluronic Acid
n=35 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=32 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=31 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Root Resorption in 3 Groups
Periapical resorption
|
12 teeth
|
8 teeth
|
15 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
Internal resorption
|
11 teeth
|
8 teeth
|
5 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
External resorption
|
7 teeth
|
6 teeth
|
5 teeth
|
|
Number of Teeth With Root Resorption in 3 Groups
No resorption
|
5 teeth
|
10 teeth
|
6 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 1 month in 3 groupsRadiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=33 Participants
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=34 Participants
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
|
3 teeth
|
1 teeth
|
0 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 3 months in 3 groupsPopulation: 1 tooth is extracted in HA group so 1 tooth is reduced but not participant
Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
|
7 teeth
|
3 teeth
|
3 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 6 months in 3 groupsPopulation: 1 tooth exfoliated in FS group so 1 tooth and 1 participant are not evaluated in FS group
Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
|
4 teeth
|
4 teeth
|
3 teeth
|
PRIMARY outcome
Timeframe: Change from Baseline at 12 months in 3 groupsPopulation: 6 participants, 12 teeth missing for xrays, 2 exfoliations from HA group; 7 participants, 8 teeth missing for xrays from FC group; 7 participants, 7 teeth missing for xrays from FS group
Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Outcome measures
| Measure |
Hyaluronic Acid
n=35 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=32 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=31 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Number of Teeth With Any Root Lesion From Radiography in 3 Groups
|
4 teeth
|
4 teeth
|
2 teeth
|
SECONDARY outcome
Timeframe: Change from Baseline at 1 monthThe survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Outcome measures
| Measure |
Hyaluronic Acid
n=51 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Restoration Stability
Stainless steel crown
|
33 teeth
|
28 teeth
|
28 teeth
|
|
Restoration Stability
Composite
|
18 teeth
|
12 teeth
|
11 teeth
|
SECONDARY outcome
Timeframe: Change from Baseline at 3 monthsPopulation: 1 tooth extracted from HA group so reduced to 50 teeth but no participant reduction
The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=39 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Restoration Stability
Stainless steel crown
|
32 teeth
|
28 teeth
|
28 teeth
|
|
Restoration Stability
Composite
|
18 teeth
|
12 teeth
|
11 teeth
|
SECONDARY outcome
Timeframe: Change from Baseline at 6 monthsPopulation: 1 tooth exfoliated from FS group so 1 tooth and 1 participant reduced from FS group
The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Outcome measures
| Measure |
Hyaluronic Acid
n=50 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=33 Participants
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Restoration Stability
Stainless steel crown
|
32 teeth
|
28 teeth
|
27 teeth
|
|
Restoration Stability
Composite
|
18 teeth
|
12 teeth
|
11 teeth
|
SECONDARY outcome
Timeframe: Change from Baseline at 12 monthsPopulation: 2 teeth exfoliated from HA group so 50 teeth reduced to 48 teeth in HA group
The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Outcome measures
| Measure |
Hyaluronic Acid
n=48 teeth
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=40 teeth
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=38 teeth
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Restoration Stability
Stainless steel crown
|
31 teeth
|
28 teeth
|
27 teeth
|
|
Restoration Stability
Composite
|
17 teeth
|
12 teeth
|
11 teeth
|
Adverse Events
Hyaluronic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Formocresol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ferric Sulfate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hyaluronic Acid
n=34 participants at risk
Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar
Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Formocresol
n=33 participants at risk
0,1 ml to the orifice of the root canals of the primary molar
Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
Ferric Sulfate
n=34 participants at risk
0,1 ml to the orifice of the root canals of the primary molar
Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
|
|---|---|---|---|
|
Infections and infestations
pulpitis
|
0.00%
0/34 • Overall study;1st month,3rd month,6th month and 12th month after the treatments
1. pain or discomfort may be seen after the treatment of the primary tooth 2. tooth can be exfoliated prematurely
|
0.00%
0/33 • Overall study;1st month,3rd month,6th month and 12th month after the treatments
1. pain or discomfort may be seen after the treatment of the primary tooth 2. tooth can be exfoliated prematurely
|
0.00%
0/34 • Overall study;1st month,3rd month,6th month and 12th month after the treatments
1. pain or discomfort may be seen after the treatment of the primary tooth 2. tooth can be exfoliated prematurely
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place