Experimental Denture Pastes

Raphael Freitas de Souza

Status: Completed

Conditions: Oral Candidiasis; Dental Plaque; Denture Stomatitis; Oral Hygiene

Treatments: Other: Dentifrice

Study type: Interventional

Funder types: Other

Identifiers

NCT01237795

FORP-PT-003

2008.1.33.58.7 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

36 participants in 4 patient groups

0.01% fluorosurfactant

Experimental group

Description:

An experimental formula for denture hygiene containing 0.01% fluorosurfactant.

Treatment:

Other: Dentifrice

1.0% chloramine T

Experimental group

Description:

An experimental formula for denture hygiene containing 1.0% chloramine T.

Treatment:

Other: Dentifrice

0.2% chloramine T

Experimental group

Description:

An experimental formula for denture hygiene containing 0.2% chloramine T.

Treatment:

Other: Dentifrice

Proprietary dentifrice.

Active Comparator group

Description:

A proprietary denture-specific dentifrice.

Treatment:

Other: Dentifrice