NCT06434142

Brief Summary

To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 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

February 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 19, 2024

Last Update Submit

May 23, 2024

Conditions

Attachment DisorderStress Disorder

Keywords

Telescopic attachmentAttachment WearZirconia

Outcome Measures

Primary Outcomes (3)

  • the mean wear values

    measurement of the mean of wear between two test groups

    at baseline

  • the mean wear values

    measurement of the mean of wear between two test groups

    after 3 months interval

  • the mean wear values

    measurement of the mean of wear between two test groups

    after 6 months interval

Study Arms (2)

patient with zirconia copy

EXPERIMENTAL

Group I (study group) was the group of patients with zirconia as a primary copings that attach to the abutment and PEEK as a secondary coping telescopic attachment that attaches to the fitting surface of the denture.

Procedure: implant overdenture

patients with cobalt chromium (CoCr) as primary copings

EXPERIMENTAL

Group II (control group) was the group of patients with cobalt chromium (CoCr) as primary copings attached to the abutment and PEEK as a secondary coping's telescopic attachment attached to the fitting surface of the denture.

Procedure: implant overdenture

Interventions

implant overdenturePROCEDURE

Following the two-stage surgical protocol, two dental implant fixtures with a length of 10 mm and a diameter of 3.7 mm were inserted at the canine area of the mandibular alveolar ridge.

patient with zirconia copypatients with cobalt chromium (CoCr) as primary copings

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • completely edentulous
  • free from any dental or systemic diseases

You may not qualify if:

  • medically ill fit patient
  • female patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamada Zaki Mahross

Cairo, 11884, Egypt

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2024

First Posted

May 30, 2024

Study Start

February 11, 2024

Primary Completion

April 20, 2024

Study Completion

May 1, 2024

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

EG(1)