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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Eusol
Sodium Hypochlorite
Anti-Infective Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014