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:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01237782
First received: November 9, 2010
Last updated: August 3, 2011
Last verified: October 2010
  Purpose

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 Intervention
Dental Plaque
Denture Stomatitis
Oral Candidiasis
Oral Hygiene
Drug: Denture soaking solution
Drug: Saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237782

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

Additional Information:
No publications provided

Responsible Party: Raphael Freitas de Souza, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01237782     History of Changes
Other Study ID Numbers: FORP-PT-002, 2009.1.1081.58.6, 2009/53788-9
Study First Received: November 9, 2010
Last Updated: August 3, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by 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
Candidiasis, Oral
Dental Plaque
Stomatitis
Stomatitis, Denture
Mycoses
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Propolis
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014