A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning

Study Overview
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Brief Summary
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This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will not be allowed to eat, drink or smoke for at least 4 hours before each visit. At the first visit, the study will be explained to you in detail and you will be allowed to ask any questions you may have before signing a consent form. You will complete a medical/dental history and the dentist will examine your mouth, during which he will poke your gums and scrape some plaque off your teeth for testing. If you do not meet the requirements to continue in the trial, you will be told that you do not need to return for more testing. If you meet requirements to continue, you will have an equal chance of being assigned to use either of the two mouth rinses being studied. You will be given a diary, toothbrush, toothpaste, and your assigned mouth rinse, with instructions on how they must be used. You will be instructed not to use any unassigned oral care products and to follow your usual eating habits. You will be given appointments to return two times within the next four weeks. At those visits, the staff will check to make sure you're following the instructions and ask how you're feeling, and the dentist will do the same thing he did during the first visit.

Detailed Description
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The primary objective of this randomized, double-blind, single-center, controlled, parallel-designed clinical study is to determine the efficacy of an experimental mouth rinse on whole-mouth mean plaque and gingivitis scores as an adjunct to brushing after four weeks of use. The secondary objectives will be to determine the efficacy of the an experimental mouth rinse as an adjunct to brushing on whole-mouth mean plaque and gingivitis measured at 2 weeks as well as a bleeding assessment according to the Bleeding Index at 2 and 4 weeks. A microbiological assessment will be performed to identify and quantify specific oral microbes to assess any change in population.

Official Title
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Determination of Anti-Plaque and Anti-Gingivitis Efficacy of One Experimental Mouthrinse Following a Baseline Oral Prophylaxis: A Four Week Study

Conditions
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Dental Plaque

Intervention / Treatment
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* Device: 19416-154-1
* Device: W002194-0221P


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 health. Must display adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect). Volunteers must read, sign, and receive a copy of the Informed Consent Form after the nature of the study has been fully explained. Must be willing to use the products according to instructions and be available for appointments. Baseline dental measurements meet protocol-specified criteria. Willingness to refrain from using all oral hygiene procedures within 12-18 hours prior to each visit. Refrain from eating, drinking or smoking for four hours prior to each visit. Exclusion Criteria: Lip, tongue, or other form of oral piercing. Fixed or removable orthodontic appliance (such as bridges, braces or dentures). Pregnancy or breast-feeding at any time during the trial. Any medical, dental or psychiatric condition, abnormality or history, or use of any product or drug, that (per protocol or in the opinion of the investigator) may increase the risk to the subject associated with trial participation or investigational product administration, or interfere with the interpretation of trial results.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.15% ethyl lauroyl arginate HCl-containing mouthrinse<br>Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks. | Device: 19416-154-1<br>* 0.15% ethyl lauroyl arginate HCl-containing mouthrinse<br>* Other names: Not Marketed;|
| Sham Comparator: 5% hydroalcohol mouthrinse<br>Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks. | Device: W002194-0221P<br>* 5% hydroalcohol mouthrinse<br>* Other names: Not Marketed;|

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) | Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation. | 4 weeks | 
| Whole-mouth Mean Plaque Index (PI) | Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole-mouth Mean Modified Gingival Index (MGI) | Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation. | 2 weeks | 
| Whole-mouth Mean Plaque Index (PI) | Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface. | 2 Weeks | 
| Whole-mouth Mean Bleeding Index (BI) | Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding. | 2 Weeks | 
| Whole-mouth Mean Bleeding Index (BI) | Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding. | 4 Weeks | 
| Microbiological Assessments - Absolute Counts | An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells and failure to detect a signal was recorded as zero. Signals were converted to absolute counts by comparison with the fluorescent signal of standards of known concentrations. The following hybridized categories of bacteria were analyzed: Actinomyces species Purple complex Yellow complex Green complex Orange complex Red complex Other species | 4 weeks | 
| Microbiological Assessments - LOG Counts | An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells and failure to detect a signal was recorded as zero. Signals were converted to log counts by comparison with the fluorescent signal of standards of known concentrations. The following hybridized categories of bacteria were analyzed: Actinomyces species Purple complex Yellow complex Green complex Orange complex Red complex Other species | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, Microorganisms