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Measuring Biting Force of Poly-amide Complete Dentures

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03253510
Enrollment
24
Registered
2017-08-18
Start date
2017-09-30
Completion date
2018-05-01
Last updated
2017-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Edentulism

Brief summary

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

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

Interventions

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

Gold standard denture base material

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Biting forceOne monthBite 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.

Countries

Egypt

Contacts

Primary ContactHadeer Abdel hadi Abd elhameed, master
hadeerhadi1990@gmail.com01158834401
Backup Contactnadia abbas

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026