Evaluation of Sodium Hypochlorite as a Denture Cleanser

Problems With Dentures Clinical Trial

Official title:

Denture Condition: Influence on Masticatory Performance, Volatile Sulfur Compounds and Presence of Biofilm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616355
• Other study ID #: 068/2008
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: June 8, 2012
• Start date: August 2011
• Est. completion date: November 2011

Study information

• Verified date: June 2012
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Problems With Dentures

Intervention

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

Locations

Country	Name	City	State
Brazil	School of Dentistry of Piracicaba, UNICAMP	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microorganisms reduction	Quantitative analysis of total microorganisms and Candida spp. Samples for culture were collected from dentures and saliva.	Baseline, 30, 60 and 90 days	Yes
Primary	Changes in base acrylic resin	Color stability and surface roughness evaluation	Baseline, 30, 60 and 90 days	No
Secondary	Patients' satisfaction with the denture cleaning protocol		30, 60 and 90 days	No