Trial Outcomes & Findings for Evaluating the Effect of Tooth Cleaning Devices on Oral Health (NCT NCT01250769)
NCT ID: NCT01250769
Last Updated: 2012-09-19
Results Overview
Residual protein concentration of interproximal plaque samples
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
14 days
Results posted on
2012-09-19
Participant Flow
Participant milestones
| Measure |
Manual Toothbrush 1
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
73
|
75
|
11
|
|
Overall Study
Day 14
|
11
|
72
|
74
|
11
|
|
Overall Study
COMPLETED
|
11
|
72
|
73
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Manual Toothbrush 1
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
Baseline characteristics by cohort
| Measure |
Manual Toothbrush 1
n=11 Participants
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=72 Participants
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=74 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
38.5 years
STANDARD_DEVIATION 12.60 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 11.60 • n=7 Participants
|
39.6 years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 12.80 • n=4 Participants
|
39.6 years
STANDARD_DEVIATION 11.30 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
Residual protein concentration of interproximal plaque samples
Outcome measures
| Measure |
Manual Toothbrush 1
n=11 Participants
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=72 Participants
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=73 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Residual Protein Concentration
|
33.5 ug/mL
Interval 28.9 to 38.2
|
28 ug/mL
Interval 26.2 to 29.8
|
20.4 ug/mL
Interval 18.6 to 22.2
|
20.2 ug/mL
Interval 15.6 to 24.9
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
Residual protein concentration of interproximal plaque samples
Outcome measures
| Measure |
Manual Toothbrush 1
n=11 Participants
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=72 Participants
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=72 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Residual Protein Concentration
|
39.7 ug/mL
Interval 33.2 to 46.2
|
36.2 ug/mL
Interval 33.7 to 38.7
|
33.6 ug/mL
Interval 31.1 to 36.2
|
33.9 ug/mL
Interval 27.4 to 40.3
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Outcome measures
| Measure |
Manual Toothbrush 1
n=11 Participants
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=72 Participants
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=74 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Modified Gingival Index
|
1.45 units on a scale
Interval 1.27 to 1.63
|
1.48 units on a scale
Interval 1.41 to 1.55
|
1.26 units on a scale
Interval 1.19 to 1.33
|
1.39 units on a scale
Interval 1.21 to 1.57
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Outcome measures
| Measure |
Manual Toothbrush 1
n=11 Participants
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=72 Participants
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=73 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Modified Gingival Index
|
1.35 units on a scale
Interval 1.18 to 1.52
|
1.44 units on a scale
Interval 1.38 to 1.51
|
1.23 units on a scale
Interval 1.17 to 1.3
|
1.41 units on a scale
Interval 1.24 to 1.58
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)
Outcome measures
| Measure |
Manual Toothbrush 1
n=11 Participants
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=72 Participants
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=74 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Gingival Bleeding Index
|
0.36 units on a scale
Interval 0.28 to 0.43
|
0.26 units on a scale
Interval 0.23 to 0.29
|
0.18 units on a scale
Interval 0.15 to 0.21
|
0.19 units on a scale
Interval 0.12 to 0.27
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)
Outcome measures
| Measure |
Manual Toothbrush 1
n=11 Participants
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=72 Participants
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=73 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 Participants
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Gingival Bleeding Index
|
0.3 units on a scale
Interval 0.23 to 0.38
|
0.26 units on a scale
Interval 0.23 to 0.29
|
0.16 units on a scale
Interval 0.13 to 0.19
|
0.2 units on a scale
Interval 0.12 to 0.27
|
Adverse Events
Manual Toothbrush 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Manual Toothbrush 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Manual Toothbrush + Interproximal Cleaning 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Manual Toothbrush + Interproximal Cleaning 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Manual Toothbrush 1
n=11 participants at risk
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=73 participants at risk
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=75 participants at risk
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 participants at risk
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Vascular disorders
Left forearm deep vein thrombosis
|
0.00%
0/11
|
0.00%
0/73
|
1.3%
1/75 • Number of events 1
|
0.00%
0/11
|
Other adverse events
| Measure |
Manual Toothbrush 1
n=11 participants at risk
Manual Toothbrush used for 1 minute twice a day.
|
Manual Toothbrush 2
n=73 participants at risk
Manual Toothbrush used for 2 minutes twice a day.
|
Manual Toothbrush + Interproximal Cleaning 1
n=75 participants at risk
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
|
Manual Toothbrush + Interproximal Cleaning 2
n=11 participants at risk
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Apthous ulcer above tooth #7 on attached gingiva
|
0.00%
0/11
|
0.00%
0/73
|
0.00%
0/75
|
9.1%
1/11 • Number of events 1
|
Additional Information
Director of Clinical Operations
Philips Healthcare, Office of Medical and Health Affairs
Phone: 425 908-1208
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Philips shall have the final authority to determine whether or not to publish study results.
- Publication restrictions are in place
Restriction type: OTHER