Efficacy of a Propolis-based Denture Cleanser

NCT ID: NCT01237782

Last Updated: 2014-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Plaque Denture Stomatitis Oral Candidiasis Oral Hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Propolis solution

A proprietary denture cleanser with propolis as the active agent.

Group Type EXPERIMENTAL

Denture soaking solution

Intervention Type DRUG

Immersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan).

Saline solultion

Physiologic saline solution.

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type DRUG

Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.

Interventions

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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).

Intervention Type DRUG

Saline solution

Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.

Intervention Type DRUG

Other Intervention Names

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Chemical methods for cleaning dentures Chemical dentures cleaners Crude drugs Propolis denture cleaner Propolis solution

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Raphael Freitas de Souza

OTHER

Sponsor Role lead

Responsible Party

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Raphael Freitas de Souza

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Raphael F de Souza, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.forp.usp.br

Institutional page of the Ribeirão Preto Dental School (research site)

Other Identifiers

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2009.1.1081.58.6

Identifier Type: OTHER

Identifier Source: secondary_id

2009/53788-9

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FORP-PT-002

Identifier Type: -

Identifier Source: org_study_id

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