Clinical trial NCT02203279: Evaluation of Three Hard Relining Materials in Complete Dentures
Official title: Evaluation of Three Hard Relining Materials in Complete Dentures: An In-vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Mandibular Dentures With Poor Retention
Keywords: Chair-side hard relining
complete denture
patients' satisfaction
supporting tissues
autopolymerized reline resins
heat cured relining material
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 36
Sex: MALE
Minimum age (years): 47
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Supporting Alveolar Mucosa Status_3
timeFrame: This will be measured at three months following relining
measure: Supporting Alveolar Mucosa Status_6
timeFrame: This variable will be assessed at six months following relining
measure: Color Stability_3
timeFrame: This will be assessed at three moths following relining
Secondary outcomes:
measure: Color Stability_6
timeFrame: This be assessed at six months following relining
measure: Peeling_3
timeFrame: This variable is going to be assessed at three months following relining
measure: Peeling_6
timeFrame: This variable is going to be assessed at six months following relining
measure: Satisfaction_3
timeFrame: This is going to be measured at three months following relining
measure: Satisfaction_6
timeFrame: This is going to be measured at six months following relining
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Removable Prosthodontics, University of Damascus Dental School
Study officials:
affiliation: PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus
name: Omar Teriaky, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Removable Prosthodontics Department, University of Damascus Dental School, Damascus
name: Muhannad Alssadi, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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citation: Pinto Lde R, Acosta EJ, Tavora FF, da Silva PM, Porto VC. Effect of repeated cycles of chemical disinfection on the roughness and hardness of hard reline acrylic resins. Gerodontology. 2010 Jun;27(2):147-53. doi: 10.1111/j.1741-2358.2009.00282.x. Epub 2009 Jun 8.
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