Back to resultsSix Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
Primary Purpose
Gingivitis, Plaque
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Colgate® Cavity Protection Toothpaste
Listerine® Cool Mint®
Concept Curve Winter Series Toothbrush
5% Hydroalcohol Mouthrinse
Mouthrinse Prototype 1
Mouthrinse Prototype 2
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
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
Sites / Locations
- Salus Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy Reference Group
5% Hydroalcohol Mouthrinse (Negative control)
Listerine® Cool Mint® (Positive control)
Mouthrinse Prototype 1
Mouthrinse Prototype 2
Arm Description
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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).
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).
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).
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).
Full Information
NCT ID
NCT04921371
First Posted
June 4, 2021
Last Updated
September 26, 2023
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
1. Study Identification
Unique Protocol Identification Number
NCT04921371
Brief Title
Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
Official Title
Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Reference Group
Arm Type
Other
Arm Description
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.
Arm Title
5% Hydroalcohol Mouthrinse (Negative control)
Arm Type
Experimental
Arm Description
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.
Arm Title
Listerine® Cool Mint® (Positive control)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mouthrinse Prototype 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Mouthrinse Prototype 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Colgate® Cavity Protection Toothpaste
Intervention Description
Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.
Intervention Type
Other
Intervention Name(s)
Listerine® Cool Mint®
Intervention Description
Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily.
Intervention Type
Other
Intervention Name(s)
Concept Curve Winter Series Toothbrush
Intervention Description
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
Intervention Type
Other
Intervention Name(s)
5% Hydroalcohol Mouthrinse
Intervention Description
Participants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily.
Intervention Type
Other
Intervention Name(s)
Mouthrinse Prototype 1
Intervention Description
Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily.
Intervention Type
Other
Intervention Name(s)
Mouthrinse Prototype 2
Intervention Description
Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily.
Primary Outcome Measure Information:
Title
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 6 Weeks of Product Use
Description
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).
Time Frame
6 weeks
Title
Whole-mouth Mean Plaque Index (Mean PI) After 6 Weeks of Product Use
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Whole-mouth Mean Plaque Index (Mean PI) After 4 Weeks of Product Use
Description
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).
Time Frame
4 weeks
Title
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 4 Weeks of Product Use
Description
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).
Time Frame
4 weeks
Title
Whole-mouth Mean Expanded Bleeding Index (Mean BI) After 4 and 6 Weeks of Product Use
Description
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).
Time Frame
4 and 6 Weeks
Title
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index After 4 and 6 Weeks of Product Use
Description
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).
Time Frame
4 and 6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffery Milleman, DDS
Organizational Affiliation
Salus Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus Research, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
http://yoda.yale.edu
Links:
URL
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Description
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Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
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