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Clinical Trials/NCT05079048
NCT05079048
Completed
Not Applicable

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

Cairo University1 site in 1 country22 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Partially Edentulous Mandible
Sponsor
Cairo University
Enrollment
22
Locations
1
Primary Endpoint
retention
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
November 30, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sharaf Mohamed Yahia

lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • exposed to radiotherapy

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • patient satisfaction(3 months to six months)

Study Sites (1)

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