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PEEK Retentive Elements Versus Conventional

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05079048
Acronym
PEEK
Enrollment
22
Registered
2021-10-15
Start date
2017-07-01
Completion date
2019-11-30
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partially Edentulous Mandible

Keywords

Ball attachment, overdenture, patient satisfaction, PEEK, retention measurement.

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.

Interventions

OTHERPEEK retentive elements

received implant-supported mandibular overdenture retained by PEEK retentive element and housings

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* exposed to radiotherapy

Design outcomes

Primary

MeasureTime frameDescription
retention3 months to six monthsmeasuring 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

MeasureTime frameDescription
patient satisfaction3 months to six monthsmeasuring 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026