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Evaluation of Sodium Hypochlorite as a Denture Cleanser

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ClinicalTrials.gov Identifier: NCT01616355
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Problems With Dentures Other: Sodium hypochlorite immersion

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm
Study Start Date : August 2011
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Other: Sodium hypochlorite immersion
    Dentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes.

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Changes in base acrylic resin [ Time Frame: Baseline, 30, 60 and 90 days ]
    Color stability and surface roughness evaluation

Secondary Outcome Measures :
  1. Patients' satisfaction with the denture cleaning protocol [ Time Frame: 30, 60 and 90 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616355

School of Dentistry of Piracicaba, UNICAMP
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
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
More Information

Responsible Party: Sheila Rodrigues de Sousa Porta, PhD Student, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01616355     History of Changes
Other Study ID Numbers: 068/2008
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012

Keywords provided by Sheila Rodrigues de Sousa Porta, University of Campinas, Brazil:
denture, complete;
sodium hypochlorite;
surface roughness;
color stability.

Additional relevant MeSH terms:
Sodium Hypochlorite
Anti-Infective Agents