Measuring Biting Force of Poly-amide Complete Dentures

NCT03253510 | Unknown

• 1 other identifier: Poly-amide complete dentures
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Poly-amide

EXPERIMENTAL

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

Other: Poly-amide

poly-methyl methacrylate

ACTIVE COMPARATOR

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

Other: Poly-methyl methacrylate

Interventions

Poly-amide OTHER

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

Also known as: Nylon

Poly-amide

Poly-methyl methacrylate OTHER

Gold standard denture base material

Also known as: PMMA

poly-methyl methacrylate

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Neuromuscular disorder and orofacial disease.
• Tempromandibular joint and muscle pain
• xerostomia or excessive salivation.
• Limited mouth opening
• Abnormal tongue behavior and/or size.
• Intraoral soft and hard tissue pathosis

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hadeer Hadi

Cairo, 002, Egypt

Location

MeSH Terms

Interventions

Nylons; Polymethyl Methacrylate

Intervention Hierarchy (Ancestors)

Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Methylmethacrylates; Polymethacrylic Acids; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Acrylic Resins; Resins, Synthetic

Central Study Contacts

Hadeer Abdel hadi Abd elhameed, master

CONTACT

01158834401; hadeerhadi1990@gmail.com

nadia abbas

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree candidate at removable prosthodontic department, Cairou

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

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 18, 2017
• Study Start: September 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

EG (1)