Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
Status and phase
Completed
Phase 1
Conditions
Plaque
Gingivitis
Treatments
Other: 5% Hydroalcohol Mouthrinse
Other: Listerine® Cool Mint®
Other: Colgate® Cavity Protection Toothpaste
Other: Mouthrinse Prototype 2
Other: Mouthrinse Prototype 1
Other: Concept Curve Winter Series Toothbrush
Details and patient eligibility
About
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.
Enrollment
157 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
157 participants in 5 patient groups
Healthy Reference Group
Other group
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.
Treatment:
Other: Colgate® Cavity Protection Toothpaste
Other: Concept Curve Winter Series Toothbrush
5% Hydroalcohol Mouthrinse (Negative control)
Experimental group
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.
Treatment:
Other: 5% Hydroalcohol Mouthrinse
Other: Colgate® Cavity Protection Toothpaste
Other: Concept Curve Winter Series Toothbrush
Listerine® Cool Mint® (Positive control)
Experimental group
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.
Treatment:
Other: Listerine® Cool Mint®
Other: Colgate® Cavity Protection Toothpaste
Other: Concept Curve Winter Series Toothbrush
Mouthrinse Prototype 1
Experimental group
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.
Treatment:
Other: Mouthrinse Prototype 1
Other: Colgate® Cavity Protection Toothpaste
Other: Concept Curve Winter Series Toothbrush
Mouthrinse Prototype 2
Experimental group
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.
Treatment:
Other: Mouthrinse Prototype 2
Other: Colgate® Cavity Protection Toothpaste
Other: Concept Curve Winter Series Toothbrush
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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