Experimental Denture Pastes

NCT ID: NCT01237795

Last Updated: 2014-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

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.

Detailed Description

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Conditions

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Dental Plaque Denture Stomatitis Oral Candidiasis Oral Hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.01% fluorosurfactant

An experimental formula for denture hygiene containing 0.01% fluorosurfactant.

Group Type EXPERIMENTAL

Dentifrice

Intervention Type OTHER

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

1.0% chloramine T

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

Group Type EXPERIMENTAL

Dentifrice

Intervention Type OTHER

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

0.2% chloramine T

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

Group Type EXPERIMENTAL

Dentifrice

Intervention Type OTHER

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

Proprietary dentifrice.

A proprietary denture-specific dentifrice.

Group Type ACTIVE_COMPARATOR

Dentifrice

Intervention Type OTHER

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

Interventions

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Dentifrice

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

Intervention Type OTHER

Other Intervention Names

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Denture-specific paste Toothpaste

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Raphael Freitas de Souza

OTHER

Sponsor Role lead

Responsible Party

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Raphael Freitas de Souza

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Helena FO Paranhos, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.forp.usp.br

Institutional page of the Ribeirão Preto Dental School (research site)

http://lattes.cnpq.br/6275169074451249

Principal Investigator´s CV

Other Identifiers

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2008.1.33.58.7

Identifier Type: OTHER

Identifier Source: secondary_id

FORP-PT-003

Identifier Type: -

Identifier Source: org_study_id

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