Measuring Quality of Life of Poly-amide Complete Dentures

Study Overview
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Brief Summary
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Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base material because of its several advantages as; good esthetics, adequate strength, easy repair and simple processing techniques. As any material it has some problems as polymerization shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was introduced into dentistry to be used as a denture base material in order to solve these problems. Polyamide denture base materials have some superior properties than PMMA as; High impact & flexural strength, excellent esthetics and less release of residual monomers4. Although being an advantage from the point of patient satisfaction, flexural property considered to be a contraindication for a denture base material. The invistigators' trial is done in order to improve rigidity of a polyamide material as well as to improve oral health related quality of life in comparison to heat cured polymethyl methacrylate.

Official Title
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Metal-reinforced Flexible Poly-amide Complete Denture Versus Heat-cured Poly-methyl Methacrylate in Terms of Oral Health Related Quality of Life; Randomized Clinical Trial

Conditions
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Denture, Complete

Intervention / Treatment
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* Other: poly-amide
* Other: poly-methyl methacrylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - i. Male or female patient with age range (45-55) and in good medical condition ii. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient inter-arch distance. iii. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. iv. Free from any tempro-mandibular joint disorder. v. The patients have good oral hygiene. Exclusion Criteria: - i. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included. ii. Patient with xerostomia or excessive salivation. iii. Patient with abnormal tongue behavior and/or size. iv. No intraoral soft and hard tissue pathosis

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 55 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: poly-amide<br>poly-amide is a thermoplastic material recently introduced to be used as a complete denture material, that provide excellent aesthetics and flexibility. | Other: poly-amide<br>* new denture base material<br>* Other names: Nylon;|
| Active Comparator: poly-methyl methacrylate<br>poly-methyl methacrylate has been commonly used as a material for constructing complete dentures and proved to have high success rate and considered to be gold standard. | Other: poly-methyl methacrylate<br>* gold standard for denture base materials<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 | one month |