An interventional study of Experimental Power Toothbrush and Flat trimmed Manual Toothbrush in Dental Devices, Home Care, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Johnson & Johnson Consumer and Personal Products Worldwide · Not applicable, Interventional, and Basic science
This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash two times a day and will not be allowed to brush their teeth at all. The mouth, teeth, tongue and gums will be looked at by a dentist. At each visit, people will rinse with a pink liquid that will dye their mouths pink. The dye is temporary and will go away by the end of the day. They may also be asked to complete a short questionnaire about their experience.
This is a 42-day, randomized, observer-blind, parallel group, single-center clinical trial. Generally healthy adults will be recruited from a database of known plaque formers. A sufficient number of subjects meeting the necessary inclusion/exclusion criteria will be enrolled into two groups, so that 140 subjects (70 per treatment group) would reasonably be expected to complete the study.
The study will have a pre-experimental phase, which will last 2 weeks followed by an experimental phase that is 4 weeks in duration. At the start of the pre-experimental phase (Day 0), subjects will undergo an initial oral exam, during which gingivitis and pre-brushing plaque evaluations will be performed. Supragingival plaque levels will be assessed on all scorable teeth according to the Rustogi Modified Navy Plaque Index (RMNPI) and gingivitis will be scored according to the Modified Gingival Index (MGI). Subjects with a whole mouth mean plaque level > 0.60 and a whole mouth mean MGI ≥ 1.75 will then brush their teeth with their assigned toothbrush using American Dental Association (ADA) Accepted fluoride toothpaste. They will be provided with written and verbal instructions to use their toothbrush twice a day, for the next 7 days (Normalization period), allowing the participants to get familiar with the assigned test product. During the second visit (Day 7), the subjects will return the products to the clinical site, and start the experimental gingivitis phase, during which they will only be allowed to use a placebo rinse (W002194-0221P) as means of oral hygiene. The objective of the experimental gingivitis phase is to standardize the levels of plaque and gingivitis in both groups.
At visit 3 (Day 14), subjects will undergo a second gingivitis and pre-brushing plaque evaluation and receive their assigned brush, instructions and diary. They will brush with their assigned toothbrush for two weeks (14 days), using an ADA accepted fluoride toothpaste. During the fourth visit (Day 28), the subjects will return to the site and undergo a third gingivitis and post-brushing plaque evaluation. At the last visit (Day 42), the study participants will undergo final gingivitis and post-brushing plaque evaluations and return all used products.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 153 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Johnson & Johnson Consumer and Personal Products Worldwide is the lead sponsor of 58 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental Power Toothbrush
Device: Experimental Power Toothbrush
Flat trimmed Manual Toothbrush
Device: Flat trimmed Manual Toothbrush
Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day with the experimental toothbrush and toothpaste provided) moving to the next quadrant of the mouth at 30-second intervals.
Also known as: Not yet marketed
Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day using the toothbrush and toothpaste provided) in their usual manner.
Also known as: Reach®
Whole-mouth Mean Modified Gingival Index (MGI) Score at 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.
Time frame: Day 42
Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28
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.
Time frame: Day 28
Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at 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.
Time frame: Day 42
Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28
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.
Time frame: Day 28
Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 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.
Time frame: Day 28 and 42
Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
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).
Time frame: Day 28 and 42
| Milestone | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) |
|---|---|---|
| Started | 76 | 77 |
| Completed | 75 | 77 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Unit on a scale | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) |
|---|---|---|
| Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42 | 1.880 ± 0.1223 | 1.770 ± 0.1443 |
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.
| Unit on a scale | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) |
|---|---|---|
| Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28 | 1.957 ± 0.1225 | 1.868 ± 0.1287 |
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.
| Units on a scale | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) |
|---|---|---|
| Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42 | 0.146 ± 0.0710 | 0.131 ± 0.0633 |
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.
| Units on a scale | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) |
|---|---|---|
| Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28 | 0.164 ± 0.0755 | 0.148 ± 0.0762 |
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.
| Units on a scale | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) |
|---|---|---|
| Day 28 | 0.232 ± 0.1066 | 0.209 ± 0.1067 |
| Day 42 | 0.208 ± 0.0993 | 0.186 ± 0.0905 |
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).
| Units on a scale | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) |
|---|---|---|
| Gingival Margin: Day 28 | 0.298 ± 0.1172 | 0.271 ± 0.1169 |
| Gingival Margin: Day 42 | 0.273 ± 0.1181 | 0.246 ± 0.0992 |
| Distal Molars: Day 28 | 0.413 ± 0.2599 | 0.399 ± 0.2175 |
| Distal Molars: Day 42 | 0.352 ± 0.2172 | 0.339 ± 0.2284 |
| Lingual of the Mandibular Incisors: Day 28 | 0.190 ± 0.2501 | 0.149 ± 0.2430 |
| Lingual of the Mandibular Incisors: Day 42 | 0.152 ± 0.1892 | 0.119 ± 0.2035 |
| Interproximal: Day 28 | 0.195 ± 0.1173 | 0.169 ± 0.1122 |
| Interproximal: Day 42 | 0.171 ± 0.1047 | 0.148 ± 0.1054 |
| Mandibular Posterior Lingual: Day 28 | 0.368 ± 0.1808 | 0.372 ± 0.1888 |
| Mandibular Posterior Lingual: Day 42 | 0.351 ± 0.1789 | 0.336 ± 0.1473 |
Collected over Up to 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Manual Toothbrush (PR-000172) | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
| Power Toothbrush (PR-009577) | 0/77 (0%) | 0/77 (0%) | 0/77 (0%) |
| Age, Continuous(years) | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) | Total |
|---|---|---|---|
| Mean | 32.4 ± 10.21 | 32.9 ± 9.61 | 32.7 ± 9.89 |
| Sex: Female, Male(Participants) | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) | Total |
|---|---|---|---|
| Female | 42 | 46 | 88 |
| Male | 34 | 31 | 65 |
| Region of Enrollment(Participants) | Manual Toothbrush (PR-000172) | Power Toothbrush (PR-009577) | Total |
|---|---|---|---|
| United States — USA | 76 | 77 | 153 |
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Johnson & Johnson Consumer and Personal Products Worldwide