Evaluation of Sodium Hypochlorite as a Denture Cleanser

June 8, 2012 updated by: Sheila Rodrigues de Sousa Porta, University of Campinas, Brazil

Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm

The present study tried to integrate all aspects of denture care: patient satisfaction with the treatment, denture decontamination and base material defects after decontamination processing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Considering that it is necessary to stipulate a simple and effective routine protocol for denture cleaning the aim of this study was to evaluate, in vivo, the efficacy of 0.5% sodium hypochlorite (NaOCl) as a denture cleanser and its effect on color stability and surface roughness of complete dentures. The patients' satisfaction with the denture cleaning method was also assessed.

Study Type

Interventional

Enrollment (Actual)

15

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
      • Piracicaba, São Paulo, Brazil, 13414-903
        • School of Dentistry of Piracicaba, UNICAMP

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • complete denture wearers; adequate general health conditions
  • ability to comply with the experimental protocol
  • time of denture use: at least one year prior the study
  • denture base material: heat-polymerized acrylic resin.

Exclusion Criteria:

  • the use of antifungal agents or antiseptic mouthwashes during the pre-experimental and experimental period.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microorganisms reduction
Time Frame: Baseline, 30, 60 and 90 days
Quantitative analysis of total microorganisms and Candida spp. Samples for culture were collected from dentures and saliva.
Baseline, 30, 60 and 90 days
Changes in base acrylic resin
Time Frame: Baseline, 30, 60 and 90 days
Color stability and surface roughness evaluation
Baseline, 30, 60 and 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients' satisfaction with the denture cleaning protocol
Time Frame: 30, 60 and 90 days
30, 60 and 90 days

Collaborators and Investigators

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

Sponsor

University of Campinas, Brazil

Investigators

  • Study Chair: Altair A Del Bel Cury, PhD, School of Dentistry of Piracicaba, State University of Campinas
  • Principal Investigator: Sheila RS Porta, PhD Student, School of Dentistry of Piracicaba, State University of Campinas

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

August 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 8, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 068/2008

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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