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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-08

Study Completion Date

2019-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Gingivitis Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

Colgate® Cavity Protection Toothpaste

Intervention Type OTHER

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

Concept Curve Winter Series Toothbrush

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Colgate® Cavity Protection Toothpaste

Intervention Type OTHER

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

Concept Curve Winter Series Toothbrush

Intervention Type OTHER

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

5% Hydroalcohol Mouthrinse

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Colgate® Cavity Protection Toothpaste

Intervention Type OTHER

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

Listerine® Cool Mint®

Intervention Type OTHER

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

Concept Curve Winter Series Toothbrush

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Colgate® Cavity Protection Toothpaste

Intervention Type OTHER

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

Concept Curve Winter Series Toothbrush

Intervention Type OTHER

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

Mouthrinse Prototype 1

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Colgate® Cavity Protection Toothpaste

Intervention Type OTHER

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

Concept Curve Winter Series Toothbrush

Intervention Type OTHER

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

Mouthrinse Prototype 2

Intervention Type OTHER

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

Interventions

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Colgate® Cavity Protection Toothpaste

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

Intervention Type OTHER

Listerine® Cool Mint®

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

Intervention Type OTHER

Concept Curve Winter Series Toothbrush

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

Intervention Type OTHER

5% Hydroalcohol Mouthrinse

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

Intervention Type OTHER

Mouthrinse Prototype 1

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

Intervention Type OTHER

Mouthrinse Prototype 2

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes