Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of an Experimental Toothbrush on the Treatment and Prevention of Gingivitis

Conditions
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Dental Devices, Home Care

Intervention / Treatment
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* Device: Experimental Power Toothbrush
* Device: Flat trimmed Manual Toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females at least 18 years of age and in good general and oral health. Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial. Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the clinical trial. Good general and oral health with manual dexterity. Willingness to refrain from all oral hygiene procedures within 18-24 hours prior to the study visit. A minimum of twenty scorable teeth with at least one scorable molar in each quadrant. A whole-mouth mean plaque level greater than 0.60 at Day 0. Whole-mouth-mean gingivitis level greater than or equal to 1.75 at Day 0. Absence of orthodontic bands, appliances, bridges, numerous crowns, extensive large restorations, excessive caries, removable orthodontic appliances or partial dentures. Absence of significant oral soft tissue pathology, excluding gingivitis, based on the visual oral examination and at the discretion of the examiner. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect). Absence of moderate/advanced periodontitis. Absence of extensive supragingival calculus. Absence of ulcerations on lips and oral mucosa. Exclusion Criteria: Currently taking steroids, antibiotic medication or any other medication within the previous month that may interfere with the efficacy evaluations. Those requiring antibiotic premedication prior to dental treatment. Participation in a dental clinical trial involving oral care products currently or within the past 28 days. Dental prophylaxis within one week prior to enrollment into the study. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial. Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.). Self-reported pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PR-009577 Toothbrush<br>Experimental Power Toothbrush | Device: Experimental Power Toothbrush<br>* 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.<br>* Other names: Not yet marketed;|
| Active Comparator: PR-000172 Toothbrush<br>Flat trimmed Manual Toothbrush | Device: Flat trimmed Manual Toothbrush<br>* 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.<br>* Other names: Reach®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |