Hygiene Protocol of Complete Dentures

Not Applicable

Completed

• Conditions: Denture Hygiene Protocol
• Interventions: Other: sodium hypochlorite; Other: sodium bicarbonate; Other: water; Other: chlorhexidine

• Registration Number: NCT01906242
• Lead Sponsor: Federal University of Pelotas

Brief Summary

Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-03
• Primary Completion: 2013-07
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-24
• Study Completion: 2013-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Complete denture wearer
• healthy
• ability to comply with the experimental protocol

Exclusion Criteria

• Candidiasis (thrush)
• use of antifungals, antibiotics or mouthwashes in the prior 3 months
• limited motor activity
• unhealthy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sodium hypochlorite	sodium hypochlorite	Patients' dentures are treated with a solution of sodium hypochlorite 0.5% once per week for 10 min
0.12% sodium bicarbonate	sodium bicarbonate	Patients' dentures are treated with sodium bicarbonate 0.12% once a week for 10 min.
Water	water	Patients' dentures are treated with water (placebo) once a week for 10 min.
0.5% chlorhexidine	chlorhexidine	Patients' dentures are treated with 0.5% chlorhexidine once a week for 10 min.

Primary Outcome Measures

Name	Time	Method
Amount of biofilm formed on the denture	14 days	Biofilm will be measured on the denture using photographs and microbial counts (baseline and after 14 days of use of one of the four hygiene protocols) after using one of the tested denture hygiene protocols. The four tested protocols (NaOCl, chlorhexidine, sodium bicarbonate, water) will be compared to see which one leads to a better hygiene of the denture.

Secondary Outcome Measures

Name	Time	Method
Odor	14 days	Patients will be asked about the odor of the solution used to soak dentures through a questionnaire

Trial Locations

Locations (1)

School of Dentistry; 🇧🇷 Pelotas, Rio Grande Do Sul, Brazil