Trial Outcomes & Findings for Powertoothbrushing for Treating Gingivitis (NCT NCT03381339)
NCT ID: NCT03381339
Last Updated: 2021-04-05
Results Overview
Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe.
COMPLETED
NA
55 participants
12 weeks post-baseline
2021-04-05
Participant Flow
Medically healthy subjects between 18 and 65 years of age were recruited by posting flyers around the Milwaukee area.
Participant milestones
| Measure |
Powered Toothbrush Intervention
Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
|
Manual Toothbrush
Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Powered Toothbrush Intervention
Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
|
Manual Toothbrush
Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Powered Toothbrush Intervention
n=3864 Bleeding Sites
Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
|
Manual Toothbrush
n=4032 Bleeding Sites
Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
|
Total
n=7896 Bleeding Sites
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.13 Years
STANDARD_DEVIATION 8.42 • n=23 Participants
|
25.75 Years
STANDARD_DEVIATION 10.16 • n=24 Participants
|
26.43 Years
STANDARD_DEVIATION 9.27 • n=47 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=23 Participants
|
14 Participants
n=24 Participants
|
30 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=23 Participants
|
10 Participants
n=24 Participants
|
17 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 Participants
n=23 Participants
|
24 Participants
n=24 Participants
|
47 Participants
n=47 Participants
|
|
Bleeding on probing
|
0.23 Average Bleeding Score
STANDARD_DEVIATION 0.08 • n=23 Participants
|
0.27 Average Bleeding Score
STANDARD_DEVIATION 0.08 • n=24 Participants
|
0.25 Average Bleeding Score
STANDARD_DEVIATION 0.09 • n=47 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-baselinePopulation: The analysis was on the number sites per patients. For BOP the score was for proportion of the bleeding sites. Similarly for MGI the score was full mouth average.
Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe.
Outcome measures
| Measure |
Powered Toothbrush Intervention
n=23 Participants
Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
|
Manual Toothbrush
n=24 Participants
Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study.
|
|---|---|---|
|
Change in Gingivitis
|
0.14 score on a scale
Standard Deviation 0.07
|
0.19 score on a scale
Standard Deviation 0.10
|
Adverse Events
Powered Toothbrush Intervention
Manual Toothbrush
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place