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Measuring Biting Force of Poly-amide Complete Dentures

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Complete Edentulism

Treatments

Other: Poly-methyl methacrylate
Other: Poly-amide

Study type

Interventional

Funder types

Other

Identifiers

NCT03253510
Poly-amide complete dentures

Details and patient eligibility

About

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

Full description

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

Enrollment

24 estimated patients

Sex

All

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

Poly-amide
Experimental group
Description:
new thermoplastic material used as a denture base, that has excellent ethetics and flexibility
Treatment:
Other: Poly-amide
poly-methyl methacrylate
Active Comparator group
Description:
Polymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability
Treatment:
Other: Poly-methyl methacrylate

Trial contacts and locations

1

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Central trial contact

nadia abbas; Hadeer Abdel hadi Abd elhameed, master

Data sourced from clinicaltrials.gov

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