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PEEK Retentive Elements Versus Conventional (PEEK)

Primary Purpose

Partially Edentulous Mandible

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PEEK retentive elements
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Partially Edentulous Mandible focused on measuring Ball attachment, overdenture, patient satisfaction, PEEK, retention measurement.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • exposed to radiotherapy

Sites / Locations

  • Mohamed Sharaf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional retentive element

PEEK retentive element

Arm Description

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

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

Outcomes

Primary Outcome Measures

retention
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

patient satisfaction
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

Full Information

First Posted
July 5, 2021
Last Updated
October 2, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05079048
Brief Title
PEEK Retentive Elements Versus Conventional
Acronym
PEEK
Official Title
Novel PEEK Retentive Elements Versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Mandible
Keywords
Ball attachment, overdenture, patient satisfaction, PEEK, retention measurement.

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional retentive element
Arm Type
Active Comparator
Arm Description
The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements,
Arm Title
PEEK retentive element
Arm Type
Experimental
Arm Description
PEEK group received implant-supported mandibular overdentures retained by PEEK housings ,
Intervention Type
Other
Intervention Name(s)
PEEK retentive elements
Other Intervention Name(s)
PEEK housing and clip
Intervention Description
received implant-supported mandibular overdenture retained by PEEK retentive element and housings
Primary Outcome Measure Information:
Title
retention
Description
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.
Time Frame
3 months to six months
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
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
Time Frame
3 months to six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: edentulous class I or II PDI classification no neuromuscular disordersand temporomandibular joint disorders Exclusion Criteria: exposed to radiotherapy
Facility Information:
Facility Name
Mohamed Sharaf
City
Banī Suwayf
ZIP/Postal Code
11625
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35265135
Citation
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.
Results Reference
derived

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PEEK Retentive Elements Versus Conventional

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