PEEK Retentive Elements Versus Conventional (PEEK)

October 2, 2021 updated by: Sharaf Mohamed Yahia, Cairo University

Novel PEEK Retentive Elements Versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial

comparing retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background. Many patients suffer from lack of retention of conventional mandibular overdentures due to loss of clip retention over time. Computer-aided design-computer-aided manufacturing (CAD-CAM) milled polyetheretherketone PEEK materials may be used for construction of retentive housing and clip for improving retention of implant-supported overdentures.

Objective . To compare retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings.

Methods: Twenty-two participants were divided into 2 equal groups (n=11). The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, while the PEEK group received implant-supported mandibular overdenture retained by PEEK retentive element and housings.The PEEK retentive elements were made by using computer-aided design and computer-aided manufacturing (CAD-CAM).Evaluation included measuring the retention by applying a gradual pulling up force by forcemeter and patient satisfaction with a 7-point visual analog scale (VAS) at overdenture insertion , 3,6, and 12 months subsequently by research interviewer.

Study Type

Interventional

Enrollment (Actual)

22

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
      • Banī Suwayf, Egypt, 11625
        • Mohamed Sharaf

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:

  • edentulous class I or II PDI classification no neuromuscular disordersand temporomandibular joint disorders

Exclusion Criteria:

  • exposed to radiotherapy

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional retentive element
The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements,
Other: PEEK retentive elements
received implant-supported mandibular overdenture retained by PEEK retentive element and housings
Other Names:
  • PEEK housing and clip
Experimental: PEEK retentive element
PEEK group received implant-supported mandibular overdentures retained by PEEK housings ,
Other: PEEK retentive elements
received implant-supported mandibular overdenture retained by PEEK retentive element and housings
Other Names:
  • PEEK housing and clip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
retention
Time Frame: 3 months to six months
measuring retention force of retentive elements using The force-meter machine (Eagle: ELT 3000) . Gradual pulling up force was applied. The record appeared at the screen of the force meter was recorded as it's single-blind measurements.
3 months to six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 3 months to six months
measuring patient satisfaction using Visual analog scale (VAS) was used for the evaluation of overall patient satisfaction. All questionnaires were taken by the same research interviewer (assisted interviewer) as he was blind about the type of prosthesis (double-blind) as the research interviewer is from another department
3 months to six 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

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)

July 1, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

October 2, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/5/2020

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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