Trial Outcomes & Findings for Adjunctive Hydrogen Peroxide for Periodontal Therapy (NCT NCT03262701)
NCT ID: NCT03262701
Last Updated: 2022-12-21
Results Overview
Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
Change between baseline and Week 4
Results posted on
2022-12-21
Participant Flow
Participant milestones
| Measure |
Hydrogen Peroxide Gel for 13weeks
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Hydrogen Peroxide Gel for 26weeks
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Scaling and Root Planing
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
9
|
|
Overall Study
COMPLETED
|
11
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hydrogen Peroxide Gel for 13weeks
n=14 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Hydrogen Peroxide Gel for 26weeks
n=17 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Scaling and Root Planing
n=8 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=14 Participants
|
14 Participants
n=17 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=14 Participants
|
3 Participants
n=17 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=39 Participants
|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 13.5 • n=14 Participants
|
54.5 years
STANDARD_DEVIATION 15.4 • n=17 Participants
|
57.1 years
STANDARD_DEVIATION 15.7 • n=8 Participants
|
52.7 years
STANDARD_DEVIATION 14.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
7 Participants
n=17 Participants
|
4 Participants
n=8 Participants
|
19 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
10 Participants
n=17 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 Participants
n=14 Participants
|
17 Participants
n=17 Participants
|
8 Participants
n=8 Participants
|
39 Participants
n=39 Participants
|
|
Bleeding On Probing
|
57.1 percent
STANDARD_DEVIATION 37.2 • n=14 Participants
|
66.9 percent
STANDARD_DEVIATION 11.9 • n=17 Participants
|
35.2 percent
STANDARD_DEVIATION 16.8 • n=8 Participants
|
53.1 percent
STANDARD_DEVIATION 22.9 • n=39 Participants
|
|
Pocket Depth
|
4.11 millimeters
STANDARD_DEVIATION 1.43 • n=14 Participants
|
3.41 millimeters
STANDARD_DEVIATION 1.16 • n=17 Participants
|
3.82 millimeters
STANDARD_DEVIATION 1.29 • n=8 Participants
|
3.78 millimeters
STANDARD_DEVIATION 1.29 • n=39 Participants
|
|
Relative Attachment Level
|
6.97 millimeters
STANDARD_DEVIATION 1.29 • n=14 Participants
|
7.11 millimeters
STANDARD_DEVIATION 0.83 • n=17 Participants
|
6.75 millimeters
STANDARD_DEVIATION 0.16 • n=8 Participants
|
6.94 millimeters
STANDARD_DEVIATION 0.76 • n=39 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and Week 4Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
Outcome measures
| Measure |
Hydrogen Peroxide Gel for 13weeks
n=11 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Hydrogen Peroxide Gel for 26weeks
n=13 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Scaling and Root Planing
n=8 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
|
|---|---|---|---|
|
Periodontal Pocket Depth Reduction
|
-0.05 millimeters
Standard Deviation 0.16
|
-0.16 millimeters
Standard Deviation 0.05
|
0.05 millimeters
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Change between baseline and Week 13Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
Outcome measures
| Measure |
Hydrogen Peroxide Gel for 13weeks
n=11 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Hydrogen Peroxide Gel for 26weeks
n=13 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Scaling and Root Planing
n=8 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
|
|---|---|---|---|
|
Periodontal Pocket Depth Reduction
|
-0.69 millimeters
Standard Deviation 0.31
|
-0.54 millimeters
Standard Deviation 0.33
|
-0.34 millimeters
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Change between baseline and Week 26Periodontal pocket depth reduction as measured by the periodontal probe from the gingival margin to the bottom of the periodontal pocket measured in millimeters.
Outcome measures
| Measure |
Hydrogen Peroxide Gel for 13weeks
n=11 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Hydrogen Peroxide Gel for 26weeks
n=13 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Scaling and Root Planing
n=8 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
|
|---|---|---|---|
|
Periodontal Pocket Depth Reduction
|
-0.70 millimeters
Standard Deviation 0.33
|
-0.49 millimeters
Standard Deviation 0.21
|
-0.30 millimeters
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Change between baseline and Week 26Change in clinical attachment level measured by using a periodontal probe with a stent used for reproducible reference in millimeters.
Outcome measures
| Measure |
Hydrogen Peroxide Gel for 13weeks
n=11 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Hydrogen Peroxide Gel for 26weeks
n=13 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Scaling and Root Planing
n=8 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
|
|---|---|---|---|
|
Change in Clinical Attachment Level
|
-0.25 millimeters
Standard Deviation 0.65
|
-0.42 millimeters
Standard Deviation 0.13
|
-0.23 millimeters
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Change between baseline and Week 26Change in bleeding on probing measured by the presence of bleeding upon probing a periodontal pocket using a periodontal probe within 30 seconds measured in percentage.
Outcome measures
| Measure |
Hydrogen Peroxide Gel for 13weeks
n=11 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 13 weeks.
Hydrogen Peroxide Gel, 13 weeks: 13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Hydrogen Peroxide Gel for 26weeks
n=13 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis and be given 1.7% hydrogen peroxide gel, oral, 0.75g, twice-daily for 15 minutes for 26 weeks.
Hydrogen Peroxide Gel, 26 weeks: 26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
|
Scaling and Root Planing
n=8 Participants
Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without any interventional hydrogen peroxide application in one or two visits.
Scaling and Root planing group: Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
|
|---|---|---|---|
|
Change in Bleeding on Probing
|
-24.1 percent
Standard Deviation 23.2
|
-34.2 percent
Standard Deviation 5.95
|
-14.2 percent
Standard Deviation 10
|
Adverse Events
Hydrogen Peroxide Gel for 13weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrogen Peroxide Gel for 26weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Scaling and Root Planing
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
Yoon Jeong Kim
Loma Linda University School of Dentistry
Phone: (909) 558-4610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place