Hygiene Protocol of Complete Dentures

NCT ID: NCT01906242

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Denture Hygiene Protocol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Water

Patients' dentures are treated with water (placebo) once a week for 10 min.

Group Type PLACEBO_COMPARATOR

water

Intervention Type OTHER

sodium hypochlorite

Patients' dentures are treated with a solution of sodium hypochlorite 0.5% once per week for 10 min

Group Type ACTIVE_COMPARATOR

sodium hypochlorite

Intervention Type OTHER

0.5% chlorhexidine

Patients' dentures are treated with 0.5% chlorhexidine once a week for 10 min.

Group Type ACTIVE_COMPARATOR

chlorhexidine

Intervention Type OTHER

0.12% sodium bicarbonate

Patients' dentures are treated with sodium bicarbonate 0.12% once a week for 10 min.

Group Type ACTIVE_COMPARATOR

sodium bicarbonate

Intervention Type OTHER

Interventions

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water

Intervention Type OTHER

sodium hypochlorite

Intervention Type OTHER

sodium bicarbonate

Intervention Type OTHER

chlorhexidine

Intervention Type OTHER

Other Intervention Names

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placebo

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Maximiliano Sergio Cenci

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tatiana Pereira-Cenci, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Maximiliano S Cenci, PhD

Role: STUDY_CHAIR

Federal University of Pelotas

Locations

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School of Dentistry

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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PPGO016

Identifier Type: -

Identifier Source: org_study_id

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