Experimental Denture Pastes

Study Overview
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Brief Summary
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This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.

Official Title
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A Randomized Trial of Experimental Dentifrices for Cleaning Dentures

Conditions
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Dental Plaque, Denture Stomatitis, Oral Candidiasis, Oral Hygiene

Intervention / Treatment
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* Other: Dentifrice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completely edentulous Good general health Patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures) Regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years Both denture bases and artificial teeth should be composed by acrylic resin Exclusion Criteria: Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures) Absence of deposits of biofilm at baseline

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.01% fluorosurfactant<br>An experimental formula for denture hygiene containing 0.01% fluorosurfactant. | Other: Dentifrice<br>* Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.<br>* Other names: Toothpaste;|
| Experimental: 1.0% chloramine T<br>An experimental formula for denture hygiene containing 1.0% chloramine T. | Other: Dentifrice<br>* Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.<br>* Other names: Toothpaste;|
| Experimental: 0.2% chloramine T<br>An experimental formula for denture hygiene containing 0.2% chloramine T. | Other: Dentifrice<br>* Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.<br>* Other names: Toothpaste;|
| Active Comparator: Proprietary dentifrice.<br>A proprietary denture-specific dentifrice. | Other: Dentifrice<br>* Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.<br>* Other names: Toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Denture plaque coverage area (%) | Relation between stained area and total surface area on the internal surface of maxillary complete dentures. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chloramine T, Complete Denture, Dental Plaque Index, Dentifrice, Denture Bases, Denture Cleansers, Edentulous Mouth, Fluorosurfactant, Oral Health, Toothpaste