Quality of Life After Denture Relining (OHRQoL)

August 21, 2013 updated by: Marina Xavier Pisani, Fundação de Amparo à Pesquisa do Estado de São Paulo

Oral Health Related Quality of Life of Edentulous Patients After Relining Mandibular Dentures With Soft and Hard Denture Liners.

Purpose: the aim of the present study was to analyze the impact of mandibular denture relining with soft or hard denture liners in the oral health related quality of life (OHRQoL) of edentulous patients.

The null hypothesis was that there would be no difference in OHRQoL findings after mandibular denture relining between patient groups treated with hard or soft denture liners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22) or a hard acrylic resin based denture liner (Kooliner; Group 2; control n=22) with chairside procedures. The OHIP EDENT (Oral Health Impact profile) questionnaire was given to patients prior to reline procedures (baseline-T0) and 90 days (T90) post relining. Three possible answers and scores were proposed for each question: never (0), sometimes (1) and almost always (2). Results were analyzed by means of the generalized linear model (p≤0.05) considering two factors: time (T0 and T90) and group (hard and soft denture liners).

Study Type

Interventional

Enrollment (Actual)

44

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
    • Sao Paulo
      • Ribeirao Preto, Sao Paulo, Brazil, 14.040-904
        • Ribeirao Preto Dental School University of Sao Paulo

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Edentulous in both jaws
  • Complete denture wearers
  • Clinically acceptable occlusal relationships
  • Healthy mucosa, i.e. with no signs of inflammation, traumatic lesions, candidiasis or hyperplasia.

Exclusion Criteria:

  • Residual vertical bone height of 10 mm or less
  • No attached mucosa in any region of mandible (type E)
  • Dentures with deteriorated intaglio surfaces
  • Dentures with large pre-existing fractures
  • Dentures with severely altered occlusal vertical dimension
  • Extremely worn artificial teeth
  • Dentures with unsatisfactory occlusions
  • Neurological diseases
  • Lack of motor coordination
  • Difficulty of understanding instructions and the conditions of the study
  • Patients with residual roots, cysts or bone spicules
  • Patients with allergies to methyl methacrylate or silicone
  • Knife-edge mandibular ridges.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Denture liner Mucopren Soft; Group 1
The existing mandibular dentures were relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22).
Other: Denture liner Mucopren Soft; Group 1
Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)
Other Names:
  • Mucopren Soft relining
Active Comparator: Denture liner Kooliner; Group 2
The existing mandibular dentures were relined with a a hard acrylic resin based denture liner (Kooliner; Group 2 n=22).
Other: Denture liner Kooliner; Group 2
Complete denture wearers had their existing mandibular dentures relined with a hard acrylic resin based denture liner (Kooliner; Group 2;n=22) with chairside procedures.
Other Names:
  • Kooliner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Oral health related quality of life at 90 days after denture relining
Time Frame: The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.

The Oral Health Related Quality of Life (OHRQoL) was assessed through the application of the questionnaire OHIP EDENT at baseline and 90 days post denture relining. Four domains developed for the Brazilian OHIP-EDENT9 were used: (D1) 'masticatory-related complaints, (D2) 'psychological discomfort and disability', (D3) 'social disability' and (D4) 'oral pain and discomfort'.

The questionnaires were carried out via interviews by one individual examiner , who was blinded for the denture liner. The interviews lasted approximately ten minutes.Three possible answers to questions one to nineteen with their scores in parenthesis were given as options: never (0), sometimes (1) or almost always (2).
The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.

Collaborators and Investigators

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

Sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: C H Lovato, pHD, Ribeirao Preto Dental School University of Sao Paulo

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

March 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 27, 2013

Last Update Submitted That Met QC Criteria

August 21, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24021985

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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