Trial Outcomes & Findings for Effect of a Multi-directional Power Toothbrush on Recession (NCT NCT02530671)
NCT ID: NCT02530671
Last Updated: 2025-01-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
12 months
Results posted on
2025-01-01
Participant Flow
Participant milestones
| Measure |
Manual Toothbrush
ADA (American Dental Association) reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Manual Toothbrush
ADA (American Dental Association) reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effect of a Multi-directional Power Toothbrush on Recession
Baseline characteristics by cohort
| Measure |
Manual Toothbrush
n=55 Participants
ADA reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
n=55 Participants
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
32 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
31 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
|
Smoker (Yes/Now)
Yes
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Smoker (Yes/Now)
No
|
48 participants
n=5 Participants
|
48 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Previous used toothbrush (MT/PT)
Manual Toothbrush
|
40 participants
n=5 Participants
|
27 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Previous used toothbrush (MT/PT)
Power Toothbrush
|
15 participants
n=5 Participants
|
28 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Manual Toothbrush
n=55 Participants
ADA reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
n=55 Participants
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Gingival Recession at Sites With Preexisting Recessions ≥2mm
|
2.09 mm
Standard Deviation 0.29
|
2.08 mm
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: 3, 6, 9 and 12 monthsA digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).
Outcome measures
| Measure |
Manual Toothbrush
n=55 Participants
ADA reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
n=54 Participants
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Bristle Splay Index (BSI) After a Specific Time-of-use
|
0.2 percentage of the original bristle field
Standard Deviation 0.2
|
0.1 percentage of the original bristle field
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Manual Toothbrush
n=55 Participants
ADA reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
n=55 Participants
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Recession at All Buccal Sites
|
0.416 mm
Standard Deviation 0.18
|
0.007 mm
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Manual Toothbrush
n=55 Participants
ADA reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
n=55 Participants
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Percentage of Recession Sites Demonstrating a Change of ≥1mm
decrease
|
14 percentage of sites
|
24 percentage of sites
|
|
Percentage of Recession Sites Demonstrating a Change of ≥1mm
increase
|
9 percentage of sites
|
5 percentage of sites
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Manual Toothbrush
n=55 Participants
ADA reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
n=55 Participants
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Pocket Probing Depths at 12months
|
1.91 mm
Standard Deviation 0.17
|
1.88 mm
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 0-3, 9-12 monthsOutcome measures
| Measure |
Manual Toothbrush
n=54 Participants
ADA reference manual toothbrush
Toothbrushing with manual toothbrush
|
Power Toothbrush
n=55 Participants
Multi-directional power toothbrush
Toothbrushing with power toothbrush
|
|---|---|---|
|
Comparison of BSI Between Periods
0-3 months
|
23.6 percentage of the original bristle field
Standard Deviation 14
|
6.4 percentage of the original bristle field
Standard Deviation 11
|
|
Comparison of BSI Between Periods
9-12months
|
28.0 percentage of the original bristle field
Standard Deviation 14.8
|
9.8 percentage of the original bristle field
Standard Deviation 12.1
|
Adverse Events
Manual Toothbrush
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Power Toothbrush
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place