NCT05079048

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

July 5, 2021

Last Update Submit

October 2, 2021

Conditions

Partially Edentulous Mandible

Keywords

Ball attachmentoverdenturepatient satisfactionPEEKretention measurement.

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months to six months

Secondary Outcomes (1)

  • patient satisfaction

    3 months to six months

Study Arms (2)

conventional retentive element

ACTIVE COMPARATOR

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

Other: PEEK retentive elements

PEEK retentive element

EXPERIMENTAL

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

Other: PEEK retentive elements

Interventions

PEEK retentive elementsOTHER

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

Also known as: PEEK housing and clip
PEEK retentive elementconventional retentive element

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • exposed to radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Sharaf

Banī Suwayf, 11625, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 35265135DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 5, 2021

First Posted

October 15, 2021

Study Start

July 1, 2017

Primary Completion

April 1, 2019

Study Completion

November 30, 2019

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations

EG(1)