Measuring Biting Force of Poly-amide Complete Dentures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2018-05-01

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

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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

Conditions

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Complete Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to two more groups in parallel for the duration of the study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Poly-amide

new thermoplastic material used as a denture base, that has excellent ethetics and flexibility

Group Type EXPERIMENTAL

Poly-amide

Intervention Type OTHER

New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response

poly-methyl methacrylate

Polymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability

Group Type ACTIVE_COMPARATOR

Poly-methyl methacrylate

Intervention Type OTHER

Gold standard denture base material

Interventions

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Poly-amide

New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response

Intervention Type OTHER

Poly-methyl methacrylate

Gold standard denture base material

Intervention Type OTHER

Other Intervention Names

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Nylon PMMA

Eligibility Criteria

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Inclusion Criteria

1. Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
2. Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
4. Free from any tempro-mandibular disease.
5. Good oral hygiene

Exclusion Criteria

1. Neuromuscular disorder and orofacial disease.
2. Tempromandibular joint and muscle pain
3. xerostomia or excessive salivation.
4. Limited mouth opening
5. Abnormal tongue behavior and/or size.
6. Intraoral soft and hard tissue pathosis

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes