Measuring Quality of Life of Versacryl Relined Dentures

Study Overview
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Brief Summary
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Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Due to drawbacks of conventional resilient liners, their longevity is questionable and they require replacement which is time consuming and costly for the dentist and patient respectively. Versacryl is a biocompatible intraoral thermo-elastic material. So versatile, it can be used to improve esthetics, retention and comfort for the patient. It softens with heat and when it is inserted to patient's mouth, it cools to body temperature providing desired rigidity. This process can be repeated many times to ensuring the comfort for the patient. Versacryl has a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material . The investigators' trial is done in order to improve the longevity and oral health related quality of life of soft liners in comparison to silicone-based soft liners.

Official Title
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Comparative Study of Silicone-based Soft Liner Versus Versacryl Liner for Mandibular Complete Denture Cases(Randomized Clinical Trial)

Conditions
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Denture Liners

Intervention / Treatment
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* Other: Versacryl soft liner
* Other: Silicone-based soft liner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completely edentulous patients wearing complete dentures. Flat mandibular residual ridge. Mandibular denture indicated for relining. Patients with minimum of 2 years and maximum of 5 years complete denture usage. Angle's class I maxillary-mandibular relationship Exclusion Criteria: Drug or alcohol abuse. Inflammatory changes in the oral cavity. Candidiasis. Any intra-oral soft tissue hyperplasia. Physical reasons that could affect follow-up. Psychiatric problems. Heavy smokers. Dentures indicated for remake.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Versacyl soft liner<br>Versacryl soft liner are flexible biocompatible materials with a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material | Other: Versacryl soft liner<br>* Versacryl has been used to construct different parts of complete and partial dentures . It can be used as thermo-elastic liner which consistency can be controlled to tailor the reline to each individual case, by adding or subtracting drops of liquid B, as explained in the directions for use. The reline can be re-adapted repeatedly, even by the patient if necessary.<br>|
| Active Comparator: Silicone-based soft liner<br>Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Resilient liners also known as 'soft liners' can be classified as temporary or permanent, cold-cured or heat-cured.Resilient liners can be divided into two main types: plasticized acrylic resins and silicone elastomers. | Other: Silicone-based soft liner<br>* gold standard for denture relining material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral health related quality of life | OHIP-49 questionnaire | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue keratinization | tissue keratinization index | 4 months |