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Efficacy of a Propolis-based Denture Cleanser

Primary Purpose

Dental Plaque, Denture Stomatitis, Oral Candidiasis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Denture soaking solution
Saline solution
Sponsored by
Raphael Freitas de Souza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Candida, Complete Denture, Dental Plaque Index, Denture Bases, Denture Cleansers, Edentulous Mouth, Mutans Streptococci, Oral Health, Propolis, Streptococcus mutans

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ribeirão Preto Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propolis solution

Saline solultion

Arm Description

A proprietary denture cleanser with propolis as the active agent.

Physiologic saline solution.

Outcomes

Primary Outcome Measures

Denture plaque coverage area (%)
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.

Secondary Outcome Measures

mutans streptococci counts (CFU)
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
Candida spp. counts (CFU)
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.

Full Information

First Posted
November 9, 2010
Last Updated
July 24, 2014
Sponsor
Raphael Freitas de Souza
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01237782
Brief Title
Efficacy of a Propolis-based Denture Cleanser
Official Title
Efficacy of a Propolis Solution for Cleaning Complete Dentures: a Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raphael Freitas de Souza
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque, Denture Stomatitis, Oral Candidiasis, Oral Hygiene
Keywords
Candida, Complete Denture, Dental Plaque Index, Denture Bases, Denture Cleansers, Edentulous Mouth, Mutans Streptococci, Oral Health, Propolis, Streptococcus mutans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propolis solution
Arm Type
Experimental
Arm Description
A proprietary denture cleanser with propolis as the active agent.
Arm Title
Saline solultion
Arm Type
Placebo Comparator
Arm Description
Physiologic saline solution.
Intervention Type
Drug
Intervention Name(s)
Denture soaking solution
Other Intervention Name(s)
Chemical methods for cleaning dentures, Chemical dentures cleaners, Crude drugs, Propolis denture cleaner, Propolis solution
Intervention Description
Immersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan).
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.
Primary Outcome Measure Information:
Title
Denture plaque coverage area (%)
Description
Relation between stained area and total surface area on the internal surface of maxillary complete dentures.
Time Frame
At the same day of the intervention, up to 1 hour following denture soaking
Secondary Outcome Measure Information:
Title
mutans streptococci counts (CFU)
Description
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
Time Frame
At the same day of the intervention, up to 1 hour following denture soaking
Title
Candida spp. counts (CFU)
Description
Microbial counts on maxilary denture base, as assessed by a conventional microbiological method.
Time Frame
At the same day of the intervention, up to 1 hour following denture soaking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael F de Souza, DDS, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribeirão Preto Dental School
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.forp.usp.br
Description
Institutional page of the Ribeirão Preto Dental School (research site)
URL
http://sistemas3.usp.br/tycho/CurriculoLattesMostrar?codpub=F7A61880194F
Description
Principal Investigator´s CV

Learn more about this trial

Efficacy of a Propolis-based Denture Cleanser

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