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Experimental Denture Pastes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237795
First Posted: November 10, 2010
Last Update Posted: July 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raphael Freitas de Souza, University of Sao Paulo
  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: Quadruple (Participant, Care Provider, 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 Raphael Freitas de Souza, University of Sao Paulo:

Primary Outcome Measures:
  • Denture plaque coverage area (%) [ Time Frame: 7 days ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237795


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

Additional Information:
Responsible Party: Raphael Freitas de Souza, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01237795     History of Changes
Other Study ID Numbers: FORP-PT-003
2008.1.33.58.7 ( Other Identifier: Institutional Review Board (FORP-USP) )
First Submitted: November 9, 2010
First Posted: November 10, 2010
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Raphael Freitas de Souza, 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:
Mechlorethamine
chloramine-T
Candidiasis
Stomatitis
Dental Plaque
Candidiasis, Oral
Stomatitis, Denture
Mycoses
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants


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