Measuring Biting Force of Poly-amide Complete Dentures

Study Overview
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Brief Summary
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Randomized clinical trial to compare between biting force of mandibular complete denture constructed from two different materials; metal reinforced polyamide and conventional PMMA,The null hypothesis of the study that there will not be a difference between biting force of the complete denture constructed from metal reinforced polyamide and PMMA

Detailed Description
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Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response. Although flexural strength, modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively low, they demonstrate great impact strength, toughness, and resistance to fracture. It was suggested that by adding glass fibers to polyamides, their stiffness and other mechanical properties could be increased. The flexural properties of nylon denture base materials has promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities, tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and PMMA when used as a denture base material and concluded that; the modulus of elasticity of polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they recommended that polyamide to be used as a denture base material it should be reinforced with metal frame

Official Title
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Comparison Between Biting Force of Heat Cured Poly Methylmethacrylate and Metal Reinforced Polyamide for Mandibular Complete Denture

Conditions
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Complete Edentulism

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: Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. Free from any tempro-mandibular disease. Good oral hygiene Exclusion Criteria: Neuromuscular disorder and orofacial disease. Tempromandibular joint and muscle pain xerostomia or excessive salivation. Limited mouth opening Abnormal tongue behavior and/or size. Intraoral soft and hard tissue pathosis

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Participants are assigned to two more groups in parallel for the duration of the study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Poly-amide<br>new thermoplastic material used as a denture base, that has excellent ethetics and flexibility | Other: Poly-amide<br>* New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response<br>* Other names: Nylon;|
| Active Comparator: poly-methyl methacrylate<br>Polymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability | Other: Poly-methyl methacrylate<br>* Gold standard denture base material<br>* Other names: PMMA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biting force | Bite force will be measured for both types of complete denture after one month of denture insertion . The recorded force during maximal clenching was obtained with I-load sensor placed between pairs of opposing teeth at one side and wood tongue depressor at the other side. The meter and depressor were located at the area of premolar/molar where there is more number of occlusal contacts with strong determinant of muscle action and subsequent great bite force. | One month |