Hygiene Protocol of Complete Dentures

November 14, 2018 updated by: Maximiliano Sergio Cenci, Federal University of Pelotas

Hygiene Protocols for Cleaning Complete Dentures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96015-560
        • School of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Water
Patients' dentures are treated with water (placebo) once a week for 10 min.
Other: water
Other Names:
  • placebo
ACTIVE_COMPARATOR: sodium hypochlorite
Patients' dentures are treated with a solution of sodium hypochlorite 0.5% once per week for 10 min
Other: sodium hypochlorite
ACTIVE_COMPARATOR: 0.5% chlorhexidine
Patients' dentures are treated with 0.5% chlorhexidine once a week for 10 min.
Other: chlorhexidine
ACTIVE_COMPARATOR: 0.12% sodium bicarbonate
Patients' dentures are treated with sodium bicarbonate 0.12% once a week for 10 min.
Other: sodium bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of biofilm formed on the denture
Time Frame: 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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odor
Time Frame: 14 days
Patients will be asked about the odor of the solution used to soak dentures through a questionnaire
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Pelotas

Investigators

  • Study Chair: Maximiliano S Cenci, PhD, Federal University of Pelotas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPGO016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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