Evaluation of Three Hard Relining Materials in Complete Dentures

September 26, 2015 updated by: Damascus University

Evaluation of Three Hard Relining Materials in Complete Dentures: An In-vivo Study

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.

Study Overview

Detailed Description

Relining denture is a process of resurfacing the tissue side of a denture to make it fit more accurately Direct relining of removable dentures with hard chair-side reline materials is suitable for improving the fit of the denture bases to the supporting tissues. Chairside reline materials are more convenient than those processed in a laboratory because the direct method is faster and does not cause clinically significant dimensional changes of the reline resin. However, when autopolymerized reline resins are used with a direct method, several problems can occur as burning sensation caused by monomers, an exothermic heat reaction and an unpleasant odor.

There are three types of hard relining chair-side materials: Dual-polymerized Visible light-polymerized as Triad DuaLine, Light Liner (Hard), Astron LC (Hard).Visible light-polymerized as Lightdon-U, Triad Hi-Flow Reline Material, Triad VLC Reline Material. Finally, autopolymerized as New Truline, Tokuyama Rebase II (Fast) , GC Reline. Other concerns related to direct reline materials include patient tolerance (taste, temperature, odor), color stability, durability and ease of handling and polishing.

Few studies evaluated the effect of disinfection solutions on relining materials properties as roughness and hardness. In one study, disinfectant solutions caused a decrease in hardness, whereas with roughness, the materials tested showed a statistically significant increase, except for Tokuyama. Depending on the examined relining materials, some materials have increased and the others have decreased surface roughness after immersion in disinfecting solutions or microwave disinfection.

All previous laboratory studies concentrated on the effects of disinfection on relining materials properties as roughness, hardness, color change. However, the clinical studies did not compare chemically cured and heat cured relining materials and their effects on supporting tissue. The aim of this study is to evaluate the clinical performance of two -chemically cured- and heat cured denture relining material after 3 and 6 months of use. In addition, the effect of hard relining materials on supporting tissues, and patients' satisfaction has not been evaluated yet.

Study Type

Interventional

Enrollment (Actual)

36

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

      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of removable prosthodontics, University of Damascus Dental School

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

47 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 45-80 year,
  • complete maxillary and lower dentures
  • Mandibular dentures with poor retention

Exclusion Criteria:

  • Patients with good stability of mandibular dentures.
  • Partial maxillary edentulous patients

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rebase II Fast
The direct chair-side relining materiel 'Rebase II Fast' will be used.
It is going to be used a direct relining material
Experimental: Flexacryl
The direct chair-side relining material Flexacryl will be used
This is going to be used as a second direct relining material
Experimental: Vertex
Vertex is a heat-cured resin material which is going to be used for indirect relining
This is going to be used as an indirect relining material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supporting Alveolar Mucosa Status_3
Time Frame: This will be measured at three months following relining

According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:

Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.

Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.

Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.

Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.

This will be measured at three months following relining
Supporting Alveolar Mucosa Status_6
Time Frame: This variable will be assessed at six months following relining

According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:

Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.

Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.

Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.

Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.

This variable will be assessed at six months following relining
Color Stability_3
Time Frame: This will be assessed at three moths following relining

The color stability variable has four degrees on clinical examination:

  1. no change
  2. simple
  3. medium
  4. large
This will be assessed at three moths following relining

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color Stability_6
Time Frame: This be assessed at six months following relining

The color stability variable has four degrees on clinical examination:

no change simple medium large

This be assessed at six months following relining
Peeling_3
Time Frame: This variable is going to be assessed at three months following relining

This variable is going to be inspected clinically and it has two categories:

  1. peeling more than 4 mm
  2. peeling less than 4 mm
This variable is going to be assessed at three months following relining
Peeling_6
Time Frame: This variable is going to be assessed at six months following relining

This variable is going to be inspected clinically and it has two categories:

  1. peeling more than 4 mm
  2. peeling less than 4 mm
This variable is going to be assessed at six months following relining
Satisfaction_3
Time Frame: This is going to be measured at three months following relining
Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.
This is going to be measured at three months following relining
Satisfaction_6
Time Frame: This is going to be measured at six months following relining
Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.
This is going to be measured at six months following relining

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Omar Teriaky, DDS MSc, PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus
  • Study Director: Muhannad Alssadi, DDS MSc PhD, Associate Professor, Removable Prosthodontics Department, University of Damascus Dental School, Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

July 28, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 26, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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