Hygiene Protocol of Complete Dentures

Denture Hygiene Protocol Clinical Trial

Official title:

Hygiene Protocols for Cleaning Complete Dentures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906242
• Other study ID #: PPGO016
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2018
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Denture Hygiene Protocol

Intervention

Other:
• water

• sodium hypochlorite

• sodium bicarbonate

• chlorhexidine

Locations

Country	Name	City	State
Brazil	School of Dentistry	Pelotas	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of biofilm formed on the denture	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.	14 days
Secondary	Odor	Patients will be asked about the odor of the solution used to soak dentures through a questionnaire	14 days