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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR-009577 Toothbrush | Experimental | Experimental Power Toothbrush |
|
| PR-000172 Toothbrush | Active Comparator | Flat trimmed Manual Toothbrush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Power Toothbrush | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Araujo | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSci Research America | Las Vegas | Nevada | 89121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Power Toothbrush (PR-009577) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Unit on a scale | Day 42 |
|
Up to 6 weeks
Safety Analysis Set includes all participants who use clinical trial test product and have any follow-up information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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No study limitations were reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Oral Health, Medical Affair & Clinical Research | Johnson & Johnson Consumer and Personal Products Worldwide | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
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|
| Flat trimmed Manual Toothbrush | Device | 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. |
|
|
| 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. | 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. | 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. | 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). | Day 28 and 42 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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.
| OG001 | 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. |
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Unit on a scale | Day 28 |
|
|
|
| Secondary | 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. | FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42. | Posted | Mean | Standard Deviation | Units on a scale | Day 42 |
|
|
|
| Secondary | 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. | FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42. | Posted | Mean | Standard Deviation | Units on a scale | Day 28 |
|
|
|
| Secondary | 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. | FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42. | Posted | Mean | Standard Deviation | Units on a scale | Day 28 and 42 |
|
|
|
| Secondary | 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). | FAS included all randomized participants who have MGI at Day 0 and at least one MGI value on Day 28 or Day 42. | Posted | Mean | Standard Deviation | Units on a scale | Day 28 and 42 |
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | 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. | 0 | 77 | 0 | 77 | 0 | 77 |
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.
| Distal Molars: Day 28 |
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| Distal Molars: Day 42 |
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| Lingual of the Mandibular Incisors: Day 28 |
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| Lingual of the Mandibular Incisors: Day 42 |
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| Interproximal: Day 28 |
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| Interproximal: Day 42 |
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| Mandibular Posterior Lingual: Day 28 |
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| Mandibular Posterior Lingual: Day 42 |
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