Trial Outcomes & Findings for Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment (NCT NCT02536781)
NCT ID: NCT02536781
Last Updated: 2017-08-02
Results Overview
Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
Days 0 and 7 after treatment
Results posted on
2017-08-02
Participant Flow
Participant milestones
| Measure |
Placebo
Mucoadhesive gel without any drug or treatment. Apply 2 time daily (Morning and Night)
|
Anthocynin
Mucoadhesive gel containing 10% of anthocyanin complex. Apply 2 times daily (Morning and night)
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Mucoadhesive gel without any drug or treatment. Apply 2 time daily (Morning and Night)
|
Anthocynin
Mucoadhesive gel containing 10% of anthocyanin complex. Apply 2 times daily (Morning and night)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment
Baseline characteristics by cohort
| Measure |
Placebol
n=36 Participants
Blank gel
Anthocyanin: Anti-inflammation gel
|
Anthocynin
n=34 Participants
Anthocyanin gel
Placebo: Blank gel
|
Total
n=70 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
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
22.1 years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
22.4 years
STANDARD_DEVIATION 1.6 • n=107 Participants
|
22.3 years
STANDARD_DEVIATION 1.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
36 participants
n=99 Participants
|
34 participants
n=107 Participants
|
70 participants
n=206 Participants
|
|
VAS scores range from 0 (no pain) to 10 (severe pain)
|
3.6 scores on a scale
STANDARD_DEVIATION 1.8 • n=99 Participants
|
3.6 scores on a scale
STANDARD_DEVIATION 1.7 • n=107 Participants
|
3.6 scores on a scale
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
wound area
|
33.3 mm^2
STANDARD_DEVIATION 37.8 • n=99 Participants
|
26.5 mm^2
STANDARD_DEVIATION 32.2 • n=107 Participants
|
29.08 mm^2
STANDARD_DEVIATION 35.01 • n=206 Participants
|
PRIMARY outcome
Timeframe: Days 0 and 7 after treatmentComparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment
Outcome measures
| Measure |
Placebol
n=34 Participants
Blank gel
Anthocyanin: Anti-inflammation gel
|
Anthocynin
n=34 Participants
Anthocyanin gel
Placebo: Blank gel
|
|---|---|---|
|
Wound Size (mm^2) Reduction
|
11.26 mm^2
Standard Deviation 14.22
|
8.92 mm^2
Standard Deviation 14.86
|
SECONDARY outcome
Timeframe: Days 0 and 7 after treatmentOutcome measures
| Measure |
Placebol
n=34 Participants
Blank gel
Anthocyanin: Anti-inflammation gel
|
Anthocynin
n=34 Participants
Anthocyanin gel
Placebo: Blank gel
|
|---|---|---|
|
VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)
|
1.53 units on a scale
Standard Deviation 1.67
|
0.96 units on a scale
Standard Deviation 0.68
|
Adverse Events
Placebol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anthocynin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Faculty of Pharmaceutical Science
Khon Kaen University
Phone: +66-43-362092
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place