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NCT06434142 Clinical Trial

Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture

Stress Disorder Clinical Trial

Official title:
Wear Assessment of Novel PEEK Telescopic Attachment for Implant Retained Mandibular Overdenture

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06434142
Other study ID # 751/306
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 11, 2024
Est. completion date May 1, 2024

Study information
Verified date May 2024
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 1, 2024
Est. primary completion date April 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: - completely edentulous - free from any dental or systemic diseases Exclusion Criteria: - medically ill fit patient - female patient

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• implant overdenture
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.

Locations
Country Name City State
Egypt Hamada Zaki Mahross Cairo

Sponsors (1)
Lead Sponsor Collaborator
Hamada Zaki Mahross Atia

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the mean wear values measurement of the mean of wear between two test groups at baseline
Primary the mean wear values measurement of the mean of wear between two test groups after 3 months interval
Primary the mean wear values measurement of the mean of wear between two test groups after 6 months interval
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