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Experimental Denture Pastes

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. Identifier: NCT01237795
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):
Raphael Freitas de Souza, University of Sao Paulo

November 9, 2010
November 10, 2010
July 28, 2014
February 2008
June 2008   (Final data collection date for primary outcome measure)
Denture plaque coverage area (%) [ Time Frame: 7 days ]
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
Same as current
Complete list of historical versions of study NCT01237795 on Archive Site
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Experimental Denture Pastes
A Randomized Trial of Experimental Dentifrices for Cleaning Dentures
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.
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Dental Plaque
  • Denture Stomatitis
  • Oral Candidiasis
  • Oral Hygiene
Other: Dentifrice
Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.
Other Names:
  • Denture-specific paste
  • Toothpaste
  • Experimental: 0.01% fluorosurfactant
    An experimental formula for denture hygiene containing 0.01% fluorosurfactant.
    Intervention: Other: Dentifrice
  • Experimental: 1.0% chloramine T
    An experimental formula for denture hygiene containing 1.0% chloramine T.
    Intervention: Other: Dentifrice
  • Experimental: 0.2% chloramine T
    An experimental formula for denture hygiene containing 0.2% chloramine T.
    Intervention: Other: Dentifrice
  • Active Comparator: Proprietary dentifrice.
    A proprietary denture-specific dentifrice.
    Intervention: Other: Dentifrice
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2009
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2008. ( Other Identifier: Institutional Review Board (FORP-USP) )
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Raphael Freitas de Souza, University of Sao Paulo
Raphael Freitas de Souza
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Principal Investigator: Helena FO Paranhos, DDS, PhD University of Sao Paulo
University of Sao Paulo
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP