Efficacy of a Propolis-based Denture Cleanser

July 24, 2014 updated by: Raphael Freitas de Souza

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14040-904
        • Ribeirão Preto Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the same day of the intervention, up to 1 hour following denture soaking

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the same day of the intervention, up to 1 hour following denture soaking
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.
At the same day of the intervention, up to 1 hour following denture soaking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raphael Freitas de Souza

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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