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

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

Study Overview

• Status: Unknown
• Conditions: Complete Edentulism
• Intervention / Treatment: Other: Poly-amide; Other: Poly-methyl methacrylate

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

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadeer Abdel hadi Abd elhameed, master; Phone Number: 01158834401; Email: hadeerhadi1990@gmail.com
• Study Contact Backup: Name: nadia abbas

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Hadeer Hadi
    • Contact: hadeer abdelhadi abdelhameed, master; Phone Number: 01158834401; Email: hadeerhadi1990@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (ACTUAL): August 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Poly-amide complete dentures

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No