Experimental Denture Pastes

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.

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Key information

Conditions

Dental Plaque Bacterial Infections and Mycoses Candidiasis Candidiasis, Oral Dental Deposits Denture Stomatitis Infections Mouth Diseases Mouth, Edentulous Mycoses Oral Candidiasis Oral Hygiene Stomatitis Stomatitis, Denture Stomatognathic Diseases Tooth Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, 14040-904, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dentifrice

Other

Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.

Other names: Denture-specific paste, Toothpaste

Primary outcomes

Denture plaque coverage area (%)

Time frame: 7 days

Relation between stained area and total surface area on the internal surface of maxillary complete dentures.

Sponsors and collaborators

Lead sponsor

Raphael Freitas de Souza

Other

Registry information

Official study title

A Randomized Trial of Experimental Dentifrices for Cleaning Dentures

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2009
First posted: Nov 10, 2010
Registry last updated: Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed