Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life

NCT03771248 | Unknown

• 1 other identifier: Prosthesis1234
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dentistry is a rapidly progressing field with innumerable advances taking place on a day to day basis. The application of newer technologies and materials has advanced the specialty of prosthodontics and the services rendered to the patients. Taking into consideration that PEEK as a material wasn't clinically investigated to be used as a material for routine use, however PEEK in removable partial dentures will help in making many steps easier and reach patients demands regarding esthetics. Also, owing to the superior mechanical and biological properties of PEEK, it will not be surprising if dentures constructed from the polymer are routinely constructed in near future.

Conditions

Partially Edentulous Mandible

Outcome Measures

Primary Outcomes (1)

• oral health impact profile

  questionnaire

  12 months

Secondary Outcomes (2)

• probing depth of abutment teeth

  12 months

• abutment mobility

  12 months

Study Arms (2)

Co-cr telescopic partial denture

ACTIVE COMPARATOR

A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium

Device: peek telescopic partial denture

PEEK telescopic partial denture

EXPERIMENTAL

A removable partial denture, its attachment is a telescopic crown made of PEEK

Device: peek telescopic partial denture

Interventions

peek telescopic partial denture DEVICE

removable partial denture

Co-cr telescopic partial denture; PEEK telescopic partial denture

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Kennedy Class I Partially edentulous patients.
• Patients with good oral hygiene.
• The distal abutment bilaterally should be a premolar.
• Abutment teeth should be in a good periodontal condition.
• Sufficient inter-arch space, any super-eruptions should be treated before beginning of treatment.
• There should be no modifications spaces in the arch to be treated, and if found it should be treated with a fixed partial denture first.
• Normal tongue size
• Medically free from any disease that might affect bone support
• Patients with no history of bad oral habits as (Bruxism or Clenching) and free from any T.M.J disorders.

You may not qualify if:

• Patients with bad oral hygiene.
• Teeth with severe malalignment.
• The arch to be treated is opposed by a completely edentulous arch.
• Unmotivated patient.
• Patient with a medical disease that will hinder his ability to be committed to the treatment.
• Patients on a radiation therapy.
• Patients with xerostomia.
• Patients with a history of drug, alcohol abuse or psychiatric disorder.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 11, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 11, 2018

Record last verified: 2018-12