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

History of Changes

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:

MedlinePlus related topics: Dentures

Drug Information available for: Sodium hypochlorite

U.S. FDA Resources

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:

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 May 23, 2013

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