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

NCT04921371 | Completed Phase 1

• 1 other identifier: CCSORC001793
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Plaque

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Whole-mouth Mean Plaque Index (Mean PI) After 4 Weeks of Product Use

  4 weeks

• Whole-mouth Mean Modified Gingival Index (Mean MGI) After 4 Weeks of Product Use

  4 weeks

• Whole-mouth Mean Expanded Bleeding Index (Mean BI) After 4 and 6 Weeks of Product Use

  4 and 6 Weeks

• Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index After 4 and 6 Weeks of Product Use

  4 and 6 Weeks

Study Arms (5)

Healthy Reference Group

OTHER

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; Other: Concept Curve Winter Series Toothbrush

5% Hydroalcohol Mouthrinse (Negative control)

EXPERIMENTAL

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; Other: Concept Curve Winter Series Toothbrush; Other: 5% Hydroalcohol Mouthrinse

Listerine® Cool Mint® (Positive control)

EXPERIMENTAL

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; Other: Listerine® Cool Mint®; Other: Concept Curve Winter Series Toothbrush

Mouthrinse Prototype 1

EXPERIMENTAL

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; Other: Concept Curve Winter Series Toothbrush; Other: Mouthrinse Prototype 1

Mouthrinse Prototype 2

EXPERIMENTAL

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; Other: Concept Curve Winter Series Toothbrush; Other: Mouthrinse Prototype 2

Interventions

Colgate® Cavity Protection Toothpaste OTHER

Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.

5% Hydroalcohol Mouthrinse (Negative control); Healthy Reference Group; Listerine® Cool Mint® (Positive control); Mouthrinse Prototype 1; Mouthrinse Prototype 2

Listerine® Cool Mint® OTHER

Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily.

Listerine® Cool Mint® (Positive control)

Concept Curve Winter Series Toothbrush OTHER

Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.

5% Hydroalcohol Mouthrinse (Negative control); Healthy Reference Group; Listerine® Cool Mint® (Positive control); Mouthrinse Prototype 1; Mouthrinse Prototype 2

5% Hydroalcohol Mouthrinse OTHER

Participants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily.

5% Hydroalcohol Mouthrinse (Negative control)

Mouthrinse Prototype 1 OTHER

Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily.

Mouthrinse Prototype 1

Mouthrinse Prototype 2 OTHER

Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily.

Mouthrinse Prototype 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (1)

• Min K, Glowacki AJ, Bosma ML, McGuire JA, Tian S, McAdoo K, DelSasso A, Fourre T, Gambogi RJ, Milleman J, Milleman KR. Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial. BMC Oral Health. 2024 May 18;24(1):578. doi: 10.1186/s12903-024-04365-9.

  PMID: 38762482 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffery Milleman, DDS

  Salus Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: October 8, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)