## Protocol Section
### Identification Module
**NCT ID:** NCT06434142

**Brief Title:** Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture

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

#### Organization Study ID Info
**ID:** 751/306
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-20

**Type:** ACTUAL

#### Start Date
**Date:** 2024-02-11

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hamada Zaki Mahross Atia

#### Responsible Party

**Investigator Affiliation:** Al-Azhar University

**Investigator Full Name:** Hamada Zaki Mahross Atia

**Investigator Title:** Assistant Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Attachment Disorder

- Stress Disorder

**Keywords:**

- Telescopic attachment

- Attachment Wear

- Zirconia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: implant overdenture

**Label:** patient with zirconia copy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: implant overdenture

**Label:** patients with cobalt chromium (CoCr) as primary copings

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- patient with zirconia copy

- patients with cobalt chromium (CoCr) as primary copings

**Description:** 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.

**Name:** implant overdenture

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** measurement of the mean of wear between two test groups

**Measure:** the mean wear values

**Time Frame:** at baseline

**Description:** measurement of the mean of wear between two test groups

**Measure:** the mean wear values

**Time Frame:** after 3 months interval

**Description:** measurement of the mean of wear between two test groups

**Measure:** the mean wear values

**Time Frame:** after 6 months interval

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* completely edentulous
* free from any dental or systemic diseases

Exclusion Criteria:

* medically ill fit patient
* female patient

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 50 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Hamada Zaki Mahross

**Zip:** 11884

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: HIGH

- As Found: Stress Disorder

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000040921

- Term: Stress Disorders, Traumatic

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6097

- Name: Chromium

- Relevance: LOW

- As Found: Unknown

- ID: M6265

- Name: Cobalt

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
