A Twelve Week Study of Supervised Mouth Rinse and Flossing
- Conditions
- Healthy
- Interventions
- Other: Colgate Cavity Protection ToothpasteOther: American Dental Association (ADA) Referenced ToothbrushOther: 5% Hydroalcohol Mouth RinseOther: REACH Dental FlossOther: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)
- Registration Number
- NCT04696536
- Lead Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Brief Summary
The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Listerine Cool Mint Mouth Rinse (Marketed product) Colgate Cavity Protection Toothpaste Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse) American Dental Association (ADA) Referenced Toothbrush Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Group 3: Flossing Performed by Dental Hygienist Colgate Cavity Protection Toothpaste Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home. Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse) Colgate Cavity Protection Toothpaste Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse) 5% Hydroalcohol Mouth Rinse Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Group 3: Flossing Performed by Dental Hygienist American Dental Association (ADA) Referenced Toothbrush Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home. Group 3: Flossing Performed by Dental Hygienist REACH Dental Floss Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home. Group 1: Listerine Cool Mint Mouth Rinse (Marketed product) American Dental Association (ADA) Referenced Toothbrush Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Group 1: Listerine Cool Mint Mouth Rinse (Marketed product) Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed) Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Group 4: Flossing under Supervision REACH Dental Floss Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home. Group 4: Flossing under Supervision Colgate Cavity Protection Toothpaste Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home. Group 4: Flossing under Supervision American Dental Association (ADA) Referenced Toothbrush Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
- Primary Outcome Measures
Name Time Method Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use 12 Weeks Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use 12 Weeks Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire 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.
- Secondary Outcome Measures
Name Time Method Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use 4 Weeks and 12 Weeks Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire 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.
Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use 4 Weeks and 12 Weeks Bleeding will be assessed according to the Gingival Bleeding Index. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 4 gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0- Absence of bleeding after 30 seconds; 1- Bleeding after 30 seconds; 2- Immediate bleeding.
Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks 4 Weeks and 12 Weeks Interproximal Plaque area will be assessed using the PMI on the facial and lingual surfaces. Distal proximal and mesial proximal will be assessed on all teeth including the distal of the second molar using the following scoring system: 0- No plaque; 1 - Separate flecks of plaque covering less than 1/3 of the area; 2 - Discrete areas or bands of plaque covering less than 1/3 of the area; 3 - Plaque covering 1/3 of the area; 4 - Plaque covering more than 1/3 but less than 2/3 of the area; 5 - Plaque covering 2/3 or more of the area.
Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use 4 Weeks Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use 4 Weeks and 12 Weeks Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use 4 Weeks Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire 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.
Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use 4 Weeks and 12 Weeks Bleeding will be assessed according to the Gingival Bleeding Index. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 4 gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0- Absence of bleeding after 30 seconds; 1- Bleeding after 30 seconds; 2- Immediate bleeding.
Trial Locations
- Locations (1)
Salus Research, Inc.
🇺🇸Fort Wayne, Indiana, United States