Trial Outcomes & Findings for Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession (NCT NCT03199118)
NCT ID: NCT03199118
Last Updated: 2021-03-22
Results Overview
measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.
COMPLETED
NA
28 participants
baseline-3 months-6 months
2021-03-22
Participant Flow
Subjects were selected from the outpatient clinic,Faculty of Dentistry, Cairo University between 30/09/2017 and 1/08/ 2019 Patients \>18 Periodontally and systemically healthy Miller class I or II buccal recession defects Presence of identifiable CEJ Clinical indication and/or patient request for recession coverage.
5 patients were excluded for not meeting inclusion criteria
Participant milestones
| Measure |
CAF+SCTG+PRF
Intervention: surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
CAF+SCTG
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession
Baseline characteristics by cohort
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
white non hispanic
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
Egypt
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
28 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline-3 months-6 monthsmeasured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Recession Depth
baseline
|
2 length in millimeters
Interval 1.0 to 4.0
|
2 length in millimeters
Interval 2.0 to 4.0
|
|
Recession Depth
3 months
|
0 length in millimeters
Interval 0.0 to 1.0
|
0 length in millimeters
Interval 0.0 to 1.0
|
|
Recession Depth
6 months
|
0 length in millimeters
Interval 0.0 to 1.0
|
0 length in millimeters
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: baseline-3 months-6 monthsIt was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Recession Width
baseline
|
1.5 length in millimeters (mm)
Interval 1.0 to 3.0
|
2 length in millimeters (mm)
Interval 1.0 to 3.0
|
|
Recession Width
3 months
|
0 length in millimeters (mm)
Interval 0.0 to 1.0
|
0 length in millimeters (mm)
Interval 0.0 to 1.0
|
|
Recession Width
6 months
|
0 length in millimeters (mm)
Interval 0.0 to 1.0
|
0 length in millimeters (mm)
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: at 6 months(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Root Coverage Gain
|
92.9 percentage of root coverage
Standard Deviation 18.2
|
91.6 percentage of root coverage
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: baseline-3 months-6 monthsmeasured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Probing Depth
baseline
|
1.71 length in millimeters(mm)
Standard Deviation 0.47
|
1.5 length in millimeters(mm)
Standard Deviation 0.65
|
|
Probing Depth
3 months
|
1.07 length in millimeters(mm)
Standard Deviation 0.27
|
1.07 length in millimeters(mm)
Standard Deviation 0.27
|
|
Probing Depth
6 months
|
1.07 length in millimeters(mm)
Standard Deviation 0.27
|
1.21 length in millimeters(mm)
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: baseline-3 months-6 monthsmeasured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Clinical Attachment Level
baseline
|
3.79 length in millimeters(mm)
Standard Deviation 0.97
|
4 length in millimeters(mm)
Standard Deviation 0.78
|
|
Clinical Attachment Level
3 months
|
2.14 length in millimeters(mm)
Standard Deviation 0.66
|
2.29 length in millimeters(mm)
Standard Deviation 0.73
|
|
Clinical Attachment Level
6 months
|
2 length in millimeters(mm)
Standard Deviation 0.69
|
2.07 length in millimeters(mm)
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: baseline-3 months-6 monthsunder local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Gingival Biotype
baseline
|
1 length in millimeters(mm)
Interval 1.0 to 1.0
|
1 length in millimeters(mm)
Interval 1.0 to 1.0
|
|
Gingival Biotype
3 months
|
3 length in millimeters(mm)
Interval 2.0 to 3.0
|
2.5 length in millimeters(mm)
Interval 2.0 to 3.0
|
|
Gingival Biotype
6 months
|
3 length in millimeters(mm)
Interval 2.0 to 4.0
|
3 length in millimeters(mm)
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: baseline-3 months-6 monthsfrom the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Width of Keratinized Gingiva
baseline
|
2.36 length in millimeters(mm)
Standard Deviation 0.63
|
2.64 length in millimeters(mm)
Standard Deviation 0.74
|
|
Width of Keratinized Gingiva
3 months
|
3.64 length in millimeters(mm)
Standard Deviation 1.08
|
3.71 length in millimeters(mm)
Standard Deviation 0.73
|
|
Width of Keratinized Gingiva
6 months
|
3.86 length in millimeters(mm)
Standard Deviation 1.03
|
4.14 length in millimeters(mm)
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: questionnaire given to the patient 6 months after the surgeryprinted yes/ no questionnaire with 3 questions: 1. would you do this surgery again? 2. would you recommend this treatment to others? 3. are you satisfied with the results?
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Patient Satisfaction
|
71.4 percentage of patients satisfied
|
64.3 percentage of patients satisfied
|
SECONDARY outcome
Timeframe: 6 monthsThe RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES. minimum value:0 maximum value: 10 which means better outcome for RES
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Root Coverage Esthetic Score (RES)
|
9.43 score on a scale
Standard Deviation 1.09
|
9.29 score on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: after 2 weeks from surgeryNumerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively
Outcome measures
| Measure |
CAF+SCTG+PRF
n=14 Participants
Intervention group : surgical procedure consisting of coronally advanced flap + SCTG +PRF membrane
Patients with class I or II gingival recession will receive treatment that consists of coronally advanced flap (CAF) with subepithelial connective tissue graft (SCTG) and platelet rich fibrin membrane(PRF)
|
Control Group:CAF+SCTG
n=14 Participants
Patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG (control group)
CAF +SCTG: the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
|
|---|---|---|
|
Post Operative Pain
|
9 score on a scale
Interval 7.0 to 10.0
|
8.5 score on a scale
Interval 5.0 to 10.0
|
Adverse Events
CAF+SCTG+PRF
CAF+SCTG
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Elbanna, assistant lecturer at the Oral Medicine and Periodontology department
Cairo University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place