A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal

Study Overview
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Brief Summary
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The whitening action of an investigative hydrogen peroxide/sodium fluoride containing mouth rinse will be evaluated through stain removal using mean Lobene Stain Index over 14 days compared to a currently marketed hydrogen peroxide containing whitening mouth rinse (Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint). A currently marketed toothpaste (Colgate® Cavity Protection) will be included as the negative control in order to compare to brushing alone. 225 healthy volunteers will be enrolled in this two week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of 5 clinic visits including 1) screening, 2) baseline 3) Day 4 (after 3 days of use), Day 8 (after 7 days of use) and Day 15 (after 14 days of use). Volunteers will maintain a diary at home to record each treatment use. Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be completed at Baseline and repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use).

Detailed Description
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Approximately 225 generally healthy subjects that meet the required inclusion/exclusion criteria will be enrolled in this 2 week, examiner-blind, single center, randomized, controlled, parallel-group clinical trial to ensure that approximately 215 subjects complete the study. At baseline, the prescreened subjects will present to the clinical site for baseline examinations (oral tissue assessment, extrinsic tooth stain assessment). Subjects will brush with water, then floss, have an oral exam and tooth stain assessment. Subjects will be randomly assigned to one of three groups using a randomized code provided by the sponsor: Negative Control - Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection). Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection) followed by rinsing twice daily with 10 ml for 60 seconds with an investigative peroxide and fluoride containing mouth rinse Brushing twice daily with an ADA - Accepted fluoride-containing dentifrice (Colgate® Cavity Protection) followed by rinsing twice daily with 15 ml for 60 seconds with Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint Immediately after randomization, subjects will begin use of their assigned test treatment. The site staff will supervise the first rinse treatment, and rinse treatments occurring on examination days. The negative control group will not have supervised brushing at the clinic to avoid the possibility of changing their usual brushing habits. All home use will be unsupervised and following label instructions. Subjects will be required to maintain a diary card to document twice-daily product use by recording their assigned oral care routine. For Clinic Visit 3, 4, and 5, subjects will be instructed to not use the treatment rinse in the morning prior to their clinic visit, because that treatment rinse will be supervised during their clinic visit. Subjects may brush as normal in the morning prior to these clinic visits. During the study, subjects will follow their usual interdental cleaning (e.g. flossing) and dietary habits. Subjects will not be allowed to use any other unassigned oral care products (mouth rinse, dentifrice, or other tooth whitening products), or have their teeth professionally polished, bleached, or whitened by a dentist or hygienist. Examinations for oral hard/soft tissue assessment and extrinsic tooth stain after the subject brushes with water and floss will be repeated at Clinic Visits 3, 4, and 5, which are on Days 4, 8 and 15 post baseline (i.e., after 3, 7, and 14 days of product use). Compliance will be evaluated at Visits 3, 4, and 5 by weighing residual volumes of returned mouth rinses and by reviewing the subject diary. Subjects will receive the ADA-Accepted fluoride containing dentifrice and a soft bristled toothbrush at their baseline visit. During the course of the study, subjects may use an interdental cleaning device to remove impacted food between the teeth and may continue using an interdental cleaning device regularly if it is part of their usual oral care regimen.

Official Title
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Whitening Action of a Hydrogen Peroxide/Sodium Fluoride Containing Mouth Rinse: A 2 Week Randomized Controlled Trial

Conditions
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Tooth Stain

Intervention / Treatment
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* Drug: Colgate® Regular Cavity Protection
* Drug: Experimental Mouth Rinse
* Other: Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 65 years. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; Able to provide written informed consent; Male or non-pregnant, non-lactating female (self-reported) Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product Medically acceptable forms of birth control that may be used by the subject and/or his/her partner Able to read and understand the local language; Able to follow study procedures; Willing for this to be the only investigational product used during this time period; and Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study. Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator Exclusion Criteria: Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, and marijuana) opiates. Females who are pregnant or breastfeeding. Males with a pregnant partner or a partner who is currently trying to become pregnant. Known sensitivity or history of significant adverse effects to any of the investigational products. Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study. Participated in tooth stain removal trials in the least 3 months Participation in any other clinical study within 30 days of Visit 1. Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson & Johnson subsidiaries, contractors of Johnson & Johnson, and the families of each). Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Negative Control, 035000513007<br>Colgate® Regular Cavity Protection | Drug: Colgate® Regular Cavity Protection<br>* Brushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection)<br>|
| Experimental: Experimental Mouth Rinse, 19545-118<br> | Drug: Experimental Mouth Rinse<br>* Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product.<br>|
| Active Comparator: Active Comparator: Mouth Rinse 037000089872<br>Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint | Other: Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint<br>* Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lobene Stain Index Composite Score at Day 15 | Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth). | 15 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lobene Stain Index Composite Score at Day 4 | Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth). | 4 Days | 
| Lobene Stain Index Composite Score at Day 8 | Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region. The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth). | 8 Days | 
| Lobene Stain Index Area Scores at Day 4 | Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region. | 4 Days | 
| Lobene Stain Index Area Scores at Day 8 | Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region. | 8 Days | 
| Lobene Stain Index Area Scores at Day 15 | Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region. | 15 Days | 
| Lobene Stain Index Intensity Scores at Day 4 | Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain. | 4 Days | 
| Lobene Stain Index Intensity Scores at Day 8 | Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain. | 8 Days | 
| Lobene Stain Index Intensity Scores at Day 15 | Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain. | 15 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staining, Intensity, Area