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Experimental Denture Pastes

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01237795
First received: November 9, 2010
Last updated: July 14, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Dental Plaque
Denture Stomatitis
Oral Candidiasis
Oral Hygiene
 Other: Dentifrice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Experimental Dentifrices for Cleaning Dentures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Denture plaque coverage area (%) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Relation between stained area and total surface area on the internal surface of maxillary complete dentures.


Enrollment: 36
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.01% fluorosurfactant
An experimental formula for denture hygiene containing 0.01% fluorosurfactant.
 Other: Dentifrice
Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.
Other Names:
  • Denture-specific paste
  • Toothpaste
Experimental: 1.0% chloramine T
An experimental formula for denture hygiene containing 1.0% chloramine T.
 Other: Dentifrice
Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.
Other Names:
  • Denture-specific paste
  • Toothpaste
Experimental: 0.2% chloramine T
An experimental formula for denture hygiene containing 0.2% chloramine T.
 Other: Dentifrice
Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.
Other Names:
  • Denture-specific paste
  • Toothpaste
Active Comparator: Proprietary dentifrice.
A proprietary denture-specific dentifrice.
 Other: Dentifrice
Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.
Other Names:
  • Denture-specific paste
  • Toothpaste

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237795

Locations
Brazil
Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Helena FO Paranhos, DDS, PhD University of Sao Paulo
  More Information

Additional Information:
Institutional page of the Ribeirão Preto Dental School (research site)  This link exits the ClinicalTrials.gov site
Principal Investigator´s CV  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Helena de Freitas Oliveira Paranhos, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01237795     History of Changes
Other Study ID Numbers: FORP-PT-003, 2008.1.33.58.7
Study First Received: November 9, 2010
Last Updated: July 14, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Chloramine T
Complete Denture
Dental Plaque Index
Dentifrice
Denture Bases
 Denture Cleansers
Edentulous Mouth
Fluorosurfactant
Oral Health
Toothpaste

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Oral
Dental Plaque
Stomatitis
Stomatitis, Denture
Mycoses
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Mechlorethamine
 Chloramine-T
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Disinfectants
Anti-Infective Agents
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on May 21, 2013