Efficacy of a Propolis-based Denture Cleanser

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Raphael Freitas de Souza, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01237782
First received: November 9, 2010
Last updated: July 24, 2014
Last verified: July 2014

November 9, 2010
July 24, 2014
September 2010
June 2011   (final data collection date for primary outcome measure)
Denture plaque coverage area (%) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ] [ Designated as safety issue: No ]
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
Denture plaque coverage area (%) [ Time Frame: Immediately after the interventions ] [ Designated as safety issue: No ]
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
Complete list of historical versions of study NCT01237782 on ClinicalTrials.gov Archive Site
  • mutans streptococci counts (CFU) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ] [ Designated as safety issue: No ]
    Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
  • Candida spp. counts (CFU) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ] [ Designated as safety issue: No ]
    Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
  • mutans streptococci counts (CFU) [ Time Frame: Immediately after the interventions ] [ Designated as safety issue: No ]
    Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
  • Candida spp. counts (CFU) [ Time Frame: Immediately after the interventions ] [ Designated as safety issue: No ]
    Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
Not Provided
Not Provided
 
Efficacy of a Propolis-based Denture Cleanser
Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial

The purpose of this study is to assess if a propolis solution is able to remove plaque and kill microbes from complete dentures. The investigators will compare the results of the propolis-based denture cleanser with those obtained with an inactive solution.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Dental Plaque
  • Denture Stomatitis
  • Oral Candidiasis
  • Oral Hygiene
  • Drug: Denture soaking solution
    Immersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan).
    Other Names:
    • Chemical methods for cleaning dentures
    • Chemical dentures cleaners
    • Crude drugs
    • Propolis denture cleaner
    • Propolis solution
  • Drug: Saline solution
    Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.
  • Experimental: Propolis solution
    A proprietary denture cleanser with propolis as the active agent.
    Intervention: Drug: Denture soaking solution
  • Placebo Comparator: Saline solultion
    Physiologic saline solution.
    Intervention: Drug: Saline solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Good general health
  • Patients requesting new complete dentures
  • Regular wearing of the same maxillary and mandibular complete dentures for at least one year
  • 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)
  • Pathologic changes in the oral cavity
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01237782
FORP-PT-002, 2009.1.1081.58.6, 2009/53788-9
No
Raphael Freitas de Souza, University of Sao Paulo
Raphael Freitas de Souza
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Raphael F de Souza, 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