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Trial record 2 of 94 for:    color II

Evaluation of Three Hard Relining Materials in Complete Dentures

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Damascus University
Sponsor:
Information provided by (Responsible Party):
Damascus University
ClinicalTrials.gov Identifier:
NCT02203279
First received: July 28, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Complete Mandibular Dentures With Poor Retention
Other: Rebase II Fast
Other: Flexacryl
Other: Vertex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Three Hard Relining Materials in Complete Dentures: An In-vivo Study

Resource links provided by NLM:


Further study details as provided by Damascus University:

Primary Outcome Measures:
  • Supporting Alveolar Mucosa Status_3 [ Time Frame: This will be measured at three months following relining ] [ Designated as safety issue: No ]

    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.


  • Supporting Alveolar Mucosa Status_6 [ Time Frame: This variable will be assessed at six months following relining ] [ Designated as safety issue: No ]

    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.


  • Color Stability_3 [ Time Frame: This will be assessed at three moths following relining ] [ Designated as safety issue: No ]

    The color stability variable has four degrees on clinical examination:

    1. no change
    2. simple
    3. medium
    4. large


Secondary Outcome Measures:
  • Color Stability_6 [ Time Frame: This be assessed at six months following relining ] [ Designated as safety issue: No ]

    The color stability variable has four degrees on clinical examination:

    no change simple medium large


  • Peeling_3 [ Time Frame: This variable is going to be assessed at three months following relining ] [ Designated as safety issue: No ]

    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

  • Peeling_6 [ Time Frame: This variable is going to be assessed at six months following relining ] [ Designated as safety issue: No ]

    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

  • Satisfaction_3 [ Time Frame: This is going to be measured at three months following relining ] [ Designated as safety issue: No ]
    Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.

  • Satisfaction_6 [ Time Frame: This is going to be measured at six months following relining ] [ Designated as safety issue: No ]
    Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.


Estimated Enrollment: 36
Study Start Date: July 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rebase II Fast
The direct chair-side relining materiel 'Rebase II Fast' will be used.
Other: Rebase II Fast
It is going to be used a direct relining material
Experimental: Flexacryl
The direct chair-side relining material Flexacryl will be used
Other: Flexacryl
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
Other: Vertex
This is going to be used as an indirect relining material

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.

  Eligibility

Ages Eligible for Study:   47 Years to 78 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02203279

Contacts
Contact: Omar Teriaky, DDS, MSc +963932765074 omarteriaky@gmail.com

Locations
Syrian Arab Republic
Department of Removable Prosthodontics, University of Damascus Dental School Recruiting
Damascus, Syrian Arab Republic, DM20AM18
Contact: Muhannad Alssadi, DDS MSc PhD    +963932844346    malssadi@gmail.com   
Principal Investigator: Omar Teriaky, DDS MSc         
Sponsors and Collaborators
Damascus University
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
  More Information

Publications:

Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02203279     History of Changes
Other Study ID Numbers: UDDS-RemPro-02-2014
Study First Received: July 28, 2014
Last Updated: July 28, 2014
Health Authority: Syria: Higher Education and Scientific Research Committee, Damascus University

Keywords provided by Damascus University:
Chair-side hard relining
complete denture
patients' satisfaction
supporting tissues
autopolymerized reline resins
heat cured relining material

ClinicalTrials.gov processed this record on November 25, 2014