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
  Purpose

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 Intervention
Problems With Dentures
Other: Sodium hypochlorite immersion

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Patients' satisfaction with the denture cleaning protocol [ Time Frame: 30, 60 and 90 days ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Sodium hypochlorite immersion
    Dentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616355

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

No publications provided

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
Study First Received: June 7, 2012
Last Updated: June 8, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Campinas, Brazil:
denture, complete;
sodium hypochlorite;
disinfection;
surface roughness;
color stability.

Additional relevant MeSH terms:
Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014