Experimental Denture Pastes

NCT01237795 | Completed

• 2 other identifiers: FORP-PT-0032008.1.33.58.7
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Denture Stomatitis; Oral Candidiasis; Oral Hygiene

Keywords

Chloramine T; Complete Denture; Dental Plaque Index; Dentifrice; Denture Bases; Denture Cleansers; Edentulous Mouth; Fluorosurfactant; Oral Health; Toothpaste

Outcome Measures

Primary Outcomes (1)

• Denture plaque coverage area (%)

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

  7 days

Study Arms (4)

0.01% fluorosurfactant

EXPERIMENTAL

An experimental formula for denture hygiene containing 0.01% fluorosurfactant.

Other: Dentifrice

1.0% chloramine T

EXPERIMENTAL

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

Other: Dentifrice

0.2% chloramine T

EXPERIMENTAL

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

Other: Dentifrice

Proprietary dentifrice.

ACTIVE COMPARATOR

A proprietary denture-specific dentifrice.

Other: Dentifrice

Interventions

Dentifrice OTHER

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

Also known as: Denture-specific paste, Toothpaste

0.01% fluorosurfactant; 0.2% chloramine T; 1.0% chloramine T; Proprietary dentifrice.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)
• Absence of deposits of biofilm at baseline

Sponsors & Collaborators

• Raphael Freitas de Souza: lead

Study Sites (1)

Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Links

• Institutional page of the Ribeirão Preto Dental School (research site)
• Principal Investigator´s CV

MeSH Terms

Conditions

Dental Plaque; Stomatitis, Denture; Candidiasis, Oral; Mouth, Edentulous

Interventions

Dentifrices; Toothpastes

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Stomatitis; Mouth Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Helena FO Paranhos, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: February 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2009
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

BR (1)