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
  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:


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:
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 April 17, 2014