Measuring Biting Force of Poly-amide Complete Dentures

Complete Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03253510
• Other study ID #: Poly-amide complete dentures
• Status: Not yet recruiting
• Phase: N/A
• First received: August 10, 2017
• Last updated: August 16, 2017
• Start date: September 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: Hadeer Abdel hadi Abd elhameed, master
• Phone: 01158834401
• Email: hadeerhadi1990[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

Other:
• Poly-amide
New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response
• Poly-methyl methacrylate
Gold standard denture base material

Locations

Country	Name	City	State
Egypt	Hadeer Hadi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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