Evaluation of Sodium Hypochlorite as a Denture Cleanser

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheila Rodrigues de Sousa Porta, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01616355
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: June 2012

June 7, 2012
June 8, 2012
August 2011
November 2011   (final data collection date for primary outcome measure)
  • Microorganisms reduction [ Time Frame: Baseline, 30, 60 and 90 days ] [ Designated as safety issue: Yes ]
    Quantitative analysis of total microorganisms and Candida spp. Samples for culture were collected from dentures and saliva.
  • Changes in base acrylic resin [ Time Frame: Baseline, 30, 60 and 90 days ] [ Designated as safety issue: No ]
    Color stability and surface roughness evaluation
Same as current
Complete list of historical versions of study NCT01616355 on ClinicalTrials.gov Archive Site
Patients' satisfaction with the denture cleaning protocol [ Time Frame: 30, 60 and 90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Sodium Hypochlorite as a Denture Cleanser
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Problems With Dentures
Other: Sodium hypochlorite immersion
Dentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01616355
068/2008
No
Sheila Rodrigues de Sousa Porta, University of Campinas, Brazil
University of Campinas, Brazil
Not Provided
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
University of Campinas, Brazil
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP