Trial Outcomes & Findings for Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis (NCT NCT01224158)
NCT ID: NCT01224158
Last Updated: 2019-12-04
Results Overview
Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
COMPLETED
NA
153 participants
Day 42
2019-12-04
Participant Flow
Participant milestones
| Measure |
Manual Toothbrush (PR-000172)
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
77
|
|
Overall Study
COMPLETED
|
75
|
77
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Manual Toothbrush (PR-000172)
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis
Baseline characteristics by cohort
| Measure |
Manual Toothbrush (PR-000172)
n=76 Participants
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
n=77 Participants
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
United States · USA
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 42Population: Full Analysis Set (FAS), included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.
Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Outcome measures
| Measure |
Manual Toothbrush (PR-000172)
n=75 Participants
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
n=77 Participants
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42
|
1.880 Unit on a scale
Standard Deviation 0.1223
|
1.770 Unit on a scale
Standard Deviation 0.1443
|
SECONDARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS), included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.
Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale with score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Outcome measures
| Measure |
Manual Toothbrush (PR-000172)
n=75 Participants
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
n=77 Participants
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28
|
1.957 Unit on a scale
Standard Deviation 0.1225
|
1.868 Unit on a scale
Standard Deviation 0.1287
|
SECONDARY outcome
Timeframe: Day 42Population: FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the total score for all tooth sites assessed divided by the total number of tooth sites assessed.
Outcome measures
| Measure |
Manual Toothbrush (PR-000172)
n=75 Participants
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
n=77 Participants
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42
|
0.146 Units on a scale
Standard Deviation 0.0710
|
0.131 Units on a scale
Standard Deviation 0.0633
|
SECONDARY outcome
Timeframe: Day 28Population: FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along the gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across the middle of the tooth and I covers the incisal area. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth. Mean RMNPI overall was calculated for each participant as the total score for all tooth sites assessed divided by the total number of tooth sites assessed.
Outcome measures
| Measure |
Manual Toothbrush (PR-000172)
n=75 Participants
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
n=77 Participants
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28
|
0.164 Units on a scale
Standard Deviation 0.0755
|
0.148 Units on a scale
Standard Deviation 0.0762
|
SECONDARY outcome
Timeframe: Day 28 and 42Population: FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.
Hard-to-reach mean score is defined as mean of scores over following areas combined; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across middle of tooth and I covers incisal area. Plaque was disclosed on a scale (0 indicates no dental plaque to 1 indicates dental plaque), Mean RPI overall was calculated for each participant as total score for all tooth sites assessed divided by total number of tooth sites assessed.
Outcome measures
| Measure |
Manual Toothbrush (PR-000172)
n=75 Participants
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
n=77 Participants
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42
Day 28
|
0.232 Units on a scale
Standard Deviation 0.1066
|
0.209 Units on a scale
Standard Deviation 0.1067
|
|
Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42
Day 42
|
0.208 Units on a scale
Standard Deviation 0.0993
|
0.186 Units on a scale
Standard Deviation 0.0905
|
SECONDARY outcome
Timeframe: Day 28 and 42Population: FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42.
Hard-to-reach mean score is defined as mean of scores over following areas separately d; a) Gingival margin (Sites A - C); b) Distal Molars (F for teeth 2, 15, 18, and 31 or the most posterior molar in that quadrant); c) Lingual of the mandibular incisors (Teeth 23-26, lingual); d) Interproximal (Sites D and F); e) Mandibular posterior lingual (Teeth 18-21, 28-31, lingual). Supra-gingival plaque was assessed on facial and lingual surfaces of teeth (7-7 each arch) using the RMNPI. The facial and lingual surfaces were divided into nine unequal segments, as follows, for a total of 18 sites per tooth: A-C along gingival margin; D and F (inter-proximal zones) directly above A-C; G-H across middle of tooth and I covers incisal area. Plaque on each area was assigned one of the following score: on a scale (0 indicates no dental plaque and 1 indicates plaque present in the measured segment of the tooth).
Outcome measures
| Measure |
Manual Toothbrush (PR-000172)
n=75 Participants
Following a placebo rinse phase of 7 days, participants brushed their teeth (twice per day using the PR-000172 toothbrush and toothpaste provided) in their usual manner up to Day 42.
|
Power Toothbrush (PR-009577)
n=77 Participants
Following a placebo rinse phase for 7 days, Participants brushed their teeth (twice per day with the experimental toothbrush PR-009577 and toothpaste provided) up to Day 42.
|
|---|---|---|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Gingival Margin: Day 28
|
0.298 Units on a scale
Standard Deviation 0.1172
|
0.271 Units on a scale
Standard Deviation 0.1169
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Gingival Margin: Day 42
|
0.273 Units on a scale
Standard Deviation 0.1181
|
0.246 Units on a scale
Standard Deviation 0.0992
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Distal Molars: Day 28
|
0.413 Units on a scale
Standard Deviation 0.2599
|
0.399 Units on a scale
Standard Deviation 0.2175
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Distal Molars: Day 42
|
0.352 Units on a scale
Standard Deviation 0.2172
|
0.339 Units on a scale
Standard Deviation 0.2284
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Lingual of the Mandibular Incisors: Day 28
|
0.190 Units on a scale
Standard Deviation 0.2501
|
0.149 Units on a scale
Standard Deviation 0.2430
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Lingual of the Mandibular Incisors: Day 42
|
0.152 Units on a scale
Standard Deviation 0.1892
|
0.119 Units on a scale
Standard Deviation 0.2035
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Interproximal: Day 28
|
0.195 Units on a scale
Standard Deviation 0.1173
|
0.169 Units on a scale
Standard Deviation 0.1122
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Interproximal: Day 42
|
0.171 Units on a scale
Standard Deviation 0.1047
|
0.148 Units on a scale
Standard Deviation 0.1054
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Mandibular Posterior Lingual: Day 28
|
0.368 Units on a scale
Standard Deviation 0.1808
|
0.372 Units on a scale
Standard Deviation 0.1888
|
|
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
Mandibular Posterior Lingual: Day 42
|
0.351 Units on a scale
Standard Deviation 0.1789
|
0.336 Units on a scale
Standard Deviation 0.1473
|
Adverse Events
Manual Toothbrush (PR-000172)
Power Toothbrush (PR-009577)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director Oral Health, Medical Affair & Clinical Research
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER