PEEK Retentive Elements Versus Conventional

NCT ID: NCT05079048

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Partially Edentulous Mandible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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conventional retentive element

The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements,

Group Type ACTIVE_COMPARATOR

PEEK retentive elements

Intervention Type OTHER

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

PEEK retentive element

PEEK group received implant-supported mandibular overdentures retained by PEEK housings ,

Group Type EXPERIMENTAL

PEEK retentive elements

Intervention Type OTHER

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

Interventions

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PEEK retentive elements

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

Intervention Type OTHER

Other Intervention Names

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PEEK housing and clip

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* exposed to radiotherapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sharaf Mohamed Yahia

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohamed Sharaf

Banī Suwayf, , Egypt

Site Status

Countries

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Egypt

References

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Sharaf MY, Eskander A, Afify MA. Novel PEEK Retentive Elements versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial. Int J Dent. 2022 Feb 28;2022:6947756. doi: 10.1155/2022/6947756. eCollection 2022.

Reference Type DERIVED
PMID: 35265135 (View on PubMed)

Other Identifiers

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19/5/2020

Identifier Type: -

Identifier Source: org_study_id