A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis

Study Overview
=================
Brief Summary
-----------------
Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis.

Detailed Description
-----------------
This is a prospective, single site, randomized, parallel, blinded clinical trial. Subjects will be randomly assigned to one of four treatment groups identified as Product A, Product B, Product C or Product D. Subjects will be screened for eligibility and entered into a washout period that is at least 7 days, during which time they will be provided with study toothbrush, toothpaste and dental floss. No oral rinses or medication that alters oral tissue health will be used or taken during the washout period. After randomization, the designated rinse will be placed into a non-transparent container so that other subjects and clinical examiners do not see the allocated rinse per the randomization schedule. Examinations for the clinical endpoints (PI, GI and BI) will be conducted at the baseline, 3-month, and 6-month visits. Interim visits will be scheduled to review diary, replenish study supplies, check study compliance, etc. Subjects will be provided Colgate Regular toothpaste, dental floss and a soft toothbrush (replaced at 3 months) for use during the 6-month study period.

Official Title
-----------------
A Prospective, Randomized, Blinded, Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis

Conditions
-----------------
Plaque

Intervention / Treatment
-----------------
* Device: 3M™ Oral Rinse
* Other: Vehicle Control Oral Rinse
* Device: PerioShield™ Oral Health Rinse
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects to whom these criteria apply will be entered into the 7-day washout Able to understand and willing to sign the Informed Consent In good general health ages 18 and older Have at least 20 natural teeth, including at least one molar and one premolar in each quadrant but excluding the third molars Willing to return to the study facility for scheduled study visits and recalls Agree not to use other oral hygiene products (non-study toothpaste, dental floss, mouth rinse, chewing gum) Agree not to brush or floss teeth after 10:00 pm the night before and not eat or drink 4 hours before an appointment Agree to the study instructions and visit schedule, including no eating or drinking for 4 hours before assessment appointments Subjects must meet the screening inclusion criteria and these additional requirements for enrollment: Completed the washout period (at least 7 days) using only the study toothbrush, dental floss and toothpaste A qualifying baseline GI of at least 1.0, as determined by the Löe-Silness Gingival Index (GI) A qualifying baseline Modified Quigley-Hein (Lobene-Soparkar Modification of Turesky's modification) Plaque Index (PI) of at least 1.5 Subjects will be excluded if they do not meet the screening exclusion criteria. Exclusion Criteria: Subjects to whom these conditions apply will be excluded: A history of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (eg, cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves, and prosthetic implants) A history of using antimicrobial oral mouth rinse during the past 3 months Taking medications which may alter gingival appearance/bleeding Use of anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health Current participation in any other clinical study within the past 30 days Reside in the same household with a subject already enrolled in the study Dry mouth due to head/neck radiation therapy Orthodontic appliances Widespread caries or chronic neglect Gross pathological changes of oral soft tissues Known history of sensitivity to oral hygiene products Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss) Pregnant or nursing or plan to become pregnant within the 6 month study duration Medical and oral conditions that, in the investigator's judgment, may compromise the subject's safety or interfere with the conduct and outcome of the study Difficult to be compliant with study visits, such as extensive travel commitments or lack of transportation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, blinded, clinical study to evaluate an oral rinse on plaque and gingivitis
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3M™ Oral Rinse<br>Subjects assigned to the Experimental Oral Rinse ('Plaque control device) will swish a volume of 15 mL of the Experimental Rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary. | Device: 3M™ Oral Rinse<br>* The Investigational Rinse contains a sugar-based surfactant using a proprietary formula. The intended use of the product is to help prevent and reduce plaque accumulation on the teeth and related gum-tissue inflammation (gingivitis).<br>* Other names: Plaque control device;|
| Placebo Comparator: Vehicle Control Oral Rinse<br>Vehicle control oral rinse (no active ingredient). Subjects assigned to the Placebo Comparator will swish a volume of 15 mL of the Placebo Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary. | Other: Vehicle Control Oral Rinse<br>* The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.<br>* Other names: Placebo Comparator;|
| Active Comparator: PerioShield™ Oral Health Rinse<br>Active control predicate device oral rinse ('Plaque control agent') Subjects assigned to the Active Comparator will swish a volume of 10 mL of the Active Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary. | Device: PerioShield™ Oral Health Rinse<br>* PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.<br>* Other names: Active Comparator;|
| Sham Comparator: Water<br>Water sham control oral rinse (not a Plaque control agent) Subjects assigned to the Sham Comparator will swish a volume of 15 mL of the Sham Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary. | Other: Water<br>* Purified bottled water containing no active ingredients.<br>* Other names: Sham Comparator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index Score Per Participant at 6 Months | Modified Quigley-Hein Plaque Index 0 = No plaque = Separate flecks of plaque at the cervical margin of the tooth = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth. = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth. = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth. = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. | 6 months | 
| Gingivitis Index Score Per Participant at 6 Months | Löe-Silness Gingival Index 0 = Absence of inflammation. = Mild inflammation: slight change in color and little change in texture. = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing. = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding. The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index Score Per Participant at 3 Months | Modified Quigley-Hein Plaque Index 0 = No plaque = Separate flecks of plaque at the cervical margin of the tooth = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth. = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth. = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth. = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. | 3 months | 
| Bleeding Assessment Per Participant at 6 Months | Eastman Interdental Bleeding Index 0 = Absence of bleeding. 1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject. | 6 months | 
| Gingivitis Index Per Participant at 3 Months | Löe-Silness Gingival Index 0 = Absence of inflammation. = Mild inflammation: slight change in color and little change in texture. = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing. = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding. The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined. | 3 months | 
| Bleeding Index Per Participant at 3 Months | Eastman Interdental Bleeding Index 0 = Absence of bleeding. 1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Plaque