Experimental Denture Pastes

Not Applicable

Completed

• Conditions: Oral Candidiasis; Dental Plaque; Oral Hygiene; Denture Stomatitis
• Interventions: Other: Dentifrice

• Registration Number: NCT01237795
• Lead Sponsor: Raphael Freitas de Souza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-06
• Study Completion: 2009-12
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0.01% fluorosurfactant	Dentifrice	An experimental formula for denture hygiene containing 0.01% fluorosurfactant.
1.0% chloramine T	Dentifrice	An experimental formula for denture hygiene containing 1.0% chloramine T.
0.2% chloramine T	Dentifrice	An experimental formula for denture hygiene containing 0.2% chloramine T.
Proprietary dentifrice.	Dentifrice	A proprietary denture-specific dentifrice.

Primary Outcome Measures

Name	Time	Method
Denture plaque coverage area (%)	7 days	Relation between stained area and total surface area on the internal surface of maxillary complete dentures.

Trial Locations

Locations (1)

Ribeirão Preto Dental School; 🇧🇷 Ribeirão Preto, São Paulo, Brazil