- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203279
Evaluation of Three Hard Relining Materials in Complete Dentures
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Damascus, Syrian Arab Republic, DM20AM18
- Department of removable prosthodontics, University of Damascus Dental School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Experimental: Flexacryl
The direct chair-side relining material Flexacryl will be used
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This is going to be used as a second direct relining material
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Experimental: Vertex
Vertex is a heat-cured resin material which is going to be used for indirect relining
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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
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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:
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This will be assessed at three moths following relining
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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
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Peeling_3
Time Frame: This variable is going to be assessed at three months following relining
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This variable is going to be inspected clinically and it has two categories:
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This variable is going to be assessed at three months following relining
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Peeling_6
Time Frame: This variable is going to be assessed at six months following relining
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This variable is going to be inspected clinically and it has two categories:
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This variable is going to be assessed at six months following relining
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Satisfaction_3
Time Frame: This is going to be measured at three months following relining
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Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.
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This is going to be measured at three months following relining
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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.
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This is going to be measured at six months following relining
|
Collaborators and Investigators
Sponsor
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
General Publications
- Al Rifaiy MQ. Shear bond strength between light polymerized hard reline resin and denture base resin subjected to long term water immersion. Saudi Dent J. 2012 Jan;24(1):23-7. doi: 10.1016/j.sdentj.2011.10.004. Epub 2011 Nov 20.
- Arima T, Murata H, Hamada T. Analysis of composition and structure of hard autopolymerizing reline resins. J Oral Rehabil. 1996 May;23(5):346-52. doi: 10.1111/j.1365-2842.1996.tb00863.x.
- 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.
- Haywood J, Basker RM, Watson CJ, Wood DJ. A comparison of three hard chairside denture reline materials. Part I. Clinical evaluation. Eur J Prosthodont Restor Dent. 2003 Dec;11(4):157-63.
- Hong G, Murata H, Li Y, Sadamori S, Hamada T. Influence of denture cleansers on the color stability of three types of denture base acrylic resin. J Prosthet Dent. 2009 Mar;101(3):205-13. doi: 10.1016/S0022-3913(09)60032-9.
- Machado AL, Breeding LC, Vergani CE, da Cruz Perez LE. Hardness and surface roughness of reline and denture base acrylic resins after repeated disinfection procedures. J Prosthet Dent. 2009 Aug;102(2):115-22. doi: 10.1016/S0022-3913(09)60120-7.
- Machado AL, Giampaolo ET, Vergani CE, Souza JF, Jorge JH. Changes in roughness of denture base and reline materials by chemical disinfection or microwave irradiation: surface roughness of denture base and reline materials. J Appl Oral Sci. 2011 Oct;19(5):521-8. doi: 10.1590/s1678-77572011000500015.
- Matsumura H, Tanoue N, Kawasaki K, Atsuta M. Clinical evaluation of a chemically cured hard denture relining material. J Oral Rehabil. 2001 Jul;28(7):640-4. doi: 10.1046/j.1365-2842.2001.00701.x.
- Murata H, Seo RS, Hamada T, Polyzois GL, Frangou MJ. Dynamic mechanical properties of hard, direct denture reline resins. J Prosthet Dent. 2007 Oct;98(4):319-26. doi: 10.1016/S0022-3913(07)60105-X.
- Ogle RE, Sorensen SE, Lewis EA. A new visible light-cured resin system applied to removable prosthodontics. J Prosthet Dent. 1986 Oct;56(4):497-506. doi: 10.1016/0022-3913(86)90397-5.
- Wyatt CC, Harrop TJ, MacEntee MI. A comparison of physical characteristics of six hard denture reline materials. J Prosthet Dent. 1986 Mar;55(3):343-6. doi: 10.1016/0022-3913(86)90117-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UDDS-RemPro-02-2014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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