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

November 9, 2010
July 14, 2011
February 2008
June 2008   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01237795 on ClinicalTrials.gov Archive Site
Not Provided
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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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01237795
FORP-PT-003, 2008.1.33.58.7
No
Helena de Freitas Oliveira Paranhos, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Helena FO Paranhos, DDS, PhD University of Sao Paulo
University of Sao Paulo
November 2010

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