Comparison Between Injection Molded Polyetheretherketone (PEEK) Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Periodontal Health of Abutment Teeth

December 13, 2018 updated by: Ahmed Hefny Zidan, Cairo University

Evaluation of Periodontal Health of the Abutment Teeth in Partial Dentures Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases

This study is aiming to evaluate the periodontal status of the abutment teeth in Polyetheretherketone ( PEEK ) framework partial dentures compared with cobalt-chromium ones in mandibular kennedy class I edentulous cases aiming to preserve the optimum periodontal health of the abutment teeth .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11311
        • Faculty of Oral and Dental Medicine 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Kennedy Class I partially edentulous subjects indicated for framework partial denture

Exclusion Criteria:

  • 1- uncooperative patients . 2- bad oral hygiene patients .

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: cobalt-chromium framework partial dentures
It's the gold standard biocompatible metal alloy used in thin sections, provide high strength and stiffness ,conduct heat and cold for a more natural experience, and is resistant to corrosion but their disadvantages include esthetic issues with metal display, oral galvanism, adverse tissue reactions,and osteolysis of abutment teeth.
Device: cobalt-chromium framework partial dentures
It's a biocompatible metal alloy used in thin sections and are less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and is resistant to corrosion. Disadvantages include hypersensitivity, esthetic issues with metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production .
Experimental: PEEK framework partial dentures
It's a promising polymer-based framework has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.
Device: PEEK framework partial dentures
It's a promising polymer-based framework material has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal status
Time Frame: Change in periodontal status will be assessed at base line , after one month and after 3 months .
periodontal status of the abutment teeth assessed by a periodontal chart .
Change in periodontal status will be assessed at base line , after one month and after 3 months .

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Abdel-Bary SK, Rostom EM, Elboarey AN. Thermoplastic Removable Partial Dentures versus Metal Cobalt-Chromium. RESEARCH JOURNAL OF PHARMACEUTICAL BIOLOGICAL AND CHEMICAL SCIENCES. 2016 Jul 1;7(4):464-70.

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 (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-11-28

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

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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