Oral Health Related Quality of Life in Cad Metallic and Poly Ether Ether Ketone (Peek) Partial Denture Frameworks in Mandibular Kennedy Class I Cases

January 23, 2025 updated by: Hend Mahmoud Mohamed Hegazi, Cairo University

Indirect CAD/CAM Removable Partial Denture Frameworks: a Comparative Study

The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with bilateral free end saddles in the mandible (Kennedy class I) with the last standing abutment second premolar
  • Opposing dentition is fully intact or restored to be intact
  • Adequate inter-arch space of at least 7mm
  • Angle's class I maxilla-mandibular relationship
  • Patients with no periodontal disease and good oral hygiene
  • Cooperative patients showing motivation to follow-up

Exclusion Criteria:

  • Periodontal affection of the abutment teeth
  • Skeletal mal-relationship
  • Unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- Patients with neuro-mascular disorders
  • Systemic disease affecting periodontal health like uncontrolled diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RPD with metallic framework
Indirectly CAD/CAM produced Metallic framework
Other: RPD with metallic framework
Indirectly CAD/CAM produced metallic RPD
Experimental: RPD with PEEK framework
Indirectly CAD/CAM produced PEEK framework
Other: RPD with PEEK framework
Indirectly CAD/CAM produced PEEK framework

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Health Related Quality of Life (OHRQoL)
Time Frame: 2 years
measured by Oral Health Impact Profile- 14 Minimum score 0 , Maximum score 56 higher scores indicate worse OHRQoL
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2021

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HendHegazi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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