Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture

NCT ID: NCT06434142

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-11
• Study Completion Date: 2024-05-01

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.

Detailed 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.

Conditions

Attachment Disorder; Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

patient with zirconia copy

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.

Group Type: EXPERIMENTAL

implant overdenture

Intervention Type: PROCEDURE

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.

patients with cobalt chromium (CoCr) as primary copings

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.

Group Type: EXPERIMENTAL

implant overdenture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• completely edentulous
• free from any dental or systemic diseases

Exclusion Criteria

• medically ill fit patient
• female patient

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hamada Zaki Mahross Atia

OTHER

Sponsor Role: lead

Responsible Party

Hamada Zaki Mahross Atia

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hamada Zaki Mahross

Cairo, , Egypt

Countries

Egypt

Other Identifiers

751/306

Identifier Type: -

Identifier Source: org_study_id