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Efficacy of a Propolis-based Denture Cleanser

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ClinicalTrials.gov Identifier: NCT01237782
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : July 28, 2014
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

Brief Summary:
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.

Condition or disease Intervention/treatment
Dental Plaque Denture Stomatitis Oral Candidiasis Oral Hygiene Drug: Denture soaking solution Drug: Saline solution

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial
Study Start Date : September 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Propolis solution
A proprietary denture cleanser with propolis as the active agent.
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
Placebo Comparator: Saline solultion
Physiologic saline solution.
Drug: Saline solution
Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.



Primary Outcome Measures :
  1. Denture plaque coverage area (%) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ]
    Relation between stained area and total surface area on the internal surface of maxillary complete dentures.


Secondary Outcome Measures :
  1. mutans streptococci counts (CFU) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ]
    Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.

  2. Candida spp. counts (CFU) [ Time Frame: At the same day of the intervention, up to 1 hour following denture soaking ]
    Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.



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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01237782


Locations
Brazil
Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
Raphael Freitas de Souza
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Raphael F de Souza, DDS, PhD University of Sao Paulo

Additional Information:
Responsible Party: Raphael Freitas de Souza, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01237782     History of Changes
Other Study ID Numbers: FORP-PT-002
2009.1.1081.58.6 ( Other Identifier: Institutional Review Board (FORP-USP) )
2009/53788-9 ( Other Grant/Funding Number: FAPESP (São Paulo Research Foundation) )
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Raphael Freitas de Souza, University of Sao Paulo:
Candida
Complete Denture
Dental Plaque Index
Denture Bases
Denture Cleansers
Edentulous Mouth
Mutans Streptococci
Oral Health
Propolis
Streptococcus mutans

Additional relevant MeSH terms:
Candidiasis
Stomatitis
Dental Plaque
Candidiasis, Oral
Stomatitis, Denture
Mycoses
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Pharmaceutical Solutions
Propolis
Anti-Infective Agents