Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque

Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque

The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque
• Intervention / Treatment: Other: Colgate® Cavity Protection Toothpaste; Other: Concept Curve Winter Series Toothbrush; Other: 5% Hydroalcohol Mouthrinse; Other: Listerine® Cool Mint®; Other: Mouthrinse Prototype 1; Other: Mouthrinse Prototype 2

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adequate oral hygiene (That is brush teeth daily and exhibit no signs or oral neglect)
• A minimum of 20 gradable teeth including 4 molars with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count
• A mean gingival index greater than or equal to (>=) 1.95 per the Modified Gingival Index at Baseline (for those in the randomized treatment group)
• A mean gingival index less than or equals to (<=) 0.75 per the Modified Gingival Index at Baseline (for those in the healthy reference group)
• A mean plaque index >= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline (for those in randomized treatment groups)
• Greater than or equal to 10 percent (%) bleeding sites at baseline (for those in randomized treatment groups)

Exclusion Criteria:

• History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
• Dental prophylaxis within four weeks prior to Screening/Baseline 1 visit
• More than three sites that have periodontal pockets depths measuring 5mm or greater in depth
• Teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group)
• History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
• Use of Antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline 1 exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Reference Group; Participants who are identified as healthy will be a comparison group. This group will participate in the examinations and plaque sampling only and will not receive a prophylaxis or product.	Other: Colgate® Cavity Protection Toothpaste; Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.; Other: Concept Curve Winter Series Toothbrush; Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Experimental: 5% Hydroalcohol Mouthrinse (Negative control); Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 milliliter (mL) of 5 percent (%) Hydroalcohol Mouthrinse twice daily (morning and evening) up to 6 weeks.	Other: Colgate® Cavity Protection Toothpaste; Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.; Other: Concept Curve Winter Series Toothbrush; Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.; Other: 5% Hydroalcohol Mouthrinse; Participants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily.
Experimental: Listerine® Cool Mint® (Positive control); Participants after brushing with Colgate® Cavity protection toothpaste and Concept curve winter series Toothbrush will rinse mouth for 30 seconds with 20 mL of Listerine® Cool Mint® twice daily (morning and evening) up to 6 weeks.	Other: Colgate® Cavity Protection Toothpaste; Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.; Other: Concept Curve Winter Series Toothbrush; Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.; Other: Listerine® Cool Mint®; Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily.
Experimental: Mouthrinse Prototype 1; Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 mL of Mouthrinse Prototype 1 twice daily (morning and evening) up to 6 weeks.	Other: Colgate® Cavity Protection Toothpaste; Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.; Other: Concept Curve Winter Series Toothbrush; Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.; Other: Mouthrinse Prototype 1; Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily.
Experimental: Mouthrinse Prototype 2; Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 mL of Mouthrinse Prototype 2 twice daily (morning and evening) up to 6 weeks.	Other: Colgate® Cavity Protection Toothpaste; Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.; Other: Concept Curve Winter Series Toothbrush; Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.; Other: Mouthrinse Prototype 2; Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 6 Weeks of Product Use	Gingivitis will be assessed by the 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).	6 weeks
Whole-mouth Mean Plaque Index (Mean PI) After 6 Weeks of Product Use	Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-mouth Mean Plaque Index (Mean PI) After 4 Weeks of Product Use	Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).	4 weeks
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 4 Weeks of Product Use	Gingivitis will be assessed by the 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).	4 weeks
Whole-mouth Mean Expanded Bleeding Index (Mean BI) After 4 and 6 Weeks of Product Use	Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (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 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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).	4 and 6 Weeks
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index After 4 and 6 Weeks of Product Use	Percent bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (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 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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).	4 and 6 Weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Principal Investigator: Jeffery Milleman, DDS, Salus Research, Inc.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): December 19, 2019

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Listerine
• Other Study ID Numbers: CCSORC001793 (Other Identifier: Johnson & Johnson Consumer Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No