PEEK Retentive Elements Versus Conventional

Not Applicable

Completed

• Conditions: Partially Edentulous Mandible
• Interventions: Other: PEEK retentive elements

• Registration Number: NCT05079048
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-11-30
• Study First Submitted: 2021-07-05
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-02
• Last Update Submitted: 2021-10-02
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

• exposed to radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional retentive element	PEEK retentive elements	The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements,
PEEK retentive element	PEEK retentive elements	PEEK group received implant-supported mandibular overdentures retained by PEEK housings ,

Primary Outcome Measures

Name	Time	Method
retention	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 Outcome Measures

Name	Time	Method
patient satisfaction	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

Trial Locations

Locations (1)

Mohamed Sharaf; 🇪🇬 Banī Suwayf, Egypt