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Evaluation of Three Hard Relining Materials in Complete Dentures

NCT02203279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-09-29

No results posted yet for this study

Summary

Purpose: The purpose of this study is to evaluate three hard relining materials after 3 and 6 months of use with mandibular complete dentures. The effect of hard relining materials on supporting tissues and patients' satisfaction will also be assessed.

Materials and Methods: 36 complete edentulous patients who already have maxillary dentures and complaining of instable mandibular dentures will be invited to participate in this study. Mandibular dentures will be relined randomly by one of three relining materials: two chairside relining materials (Tokuyama Rebase II Fast, Tokuyama Dental Co, Japan), and (Flexacryl Hard, Lang Co, USA) and one heat cured acrylic resin (Vertex, Dental technology Co, Holland).

The color stability of relining material, peeling, and the effect on supporting tissue will be assessed by two separate prosthodontists after 3 and 6 months of follow up. In addition, patients will be asked to grade there overall satisfaction on a Visual Analogue Scale (VAS) ranging from 0 to 100.

Conditions

  • Complete Mandibular Dentures With Poor Retention

Interventions

OTHER

Rebase II Fast

It is going to be used a direct relining material

OTHER

Flexacryl

This is going to be used as a second direct relining material

OTHER

Vertex

This is going to be used as an indirect relining material

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Omar Teriaky, DDS MSc · PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus

  • Muhannad Alssadi, DDS MSc PhD · Associate Professor, Removable Prosthodontics Department, University of Damascus Dental School, Damascus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
47 Years
Max Age
78 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • Syria

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203279 on ClinicalTrials.gov