## Protocol Section
### Identification Module
**NCT ID:** NCT06422260

**Brief Title:** Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials

**Official Title:** Clinical and Radiographic Outcomes of Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials

#### Organization Study ID Info
**ID:** ADMNF-0030324
#### Organization
**Class:** OTHER
**Full Name:** Menoufia University
### Status Module
#### Completion Date
**Date:** 2025-01-29

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-22

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Menoufia University

#### Responsible Party

**Investigator Affiliation:** Menoufia University

**Investigator Full Name:** Mohammed El-Sawy

**Investigator Title:** lecturer, Department of prosthodontics, principle investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.

**Detailed Description:** One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.

### Conditions Module

**Conditions:**

- Prosthesis Survival

- Bone Loss

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 4 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM

**Intervention Names:**

- Other: Prosthesis superstructure

**Label:** Porcelin fused to metal (PFM) group

#### Arm Group 2

**Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics

**Intervention Names:**

- Other: Prosthesis superstructure

**Label:** Zirconia group

#### Arm Group 3

**Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK

**Intervention Names:**

- Other: Prosthesis superstructure

**Label:** Polyetheretherketone (PEEK) group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Polyetheretherketone (PEEK) group

- Porcelin fused to metal (PFM) group

- Zirconia group

**Description:** Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials

**Name:** Prosthesis superstructure

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement of alveolar bone loss around implants.

**Measure:** Bone loss

**Time Frame:** 4 years

#### Secondary Outcomes

**Description:** Such as fracture of the prosthesis.

**Measure:** Clinical performance of the prosthesis superstructure

**Time Frame:** 4 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* No systemic diseases that might alter the tissue response to implantation.
* Mobility grade 3 at the site of the 4 lateral incisors.
* sufficient available inter-arch space
* normal maxillomandibular relation.
* no temporomandibular joint

Exclusion Criteria:

* Grade 1 or 2 mobility at the incisor's region.
* Patients with systematic diseases that contraindicate implant placement.

**Maximum Age:** 50 Years

**Minimum Age:** 30 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** 60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Dr_sawy@windowslive.com

**Name:** Mohammed A. El-Sawy, PhD

**Phone:** 01061314522

**Role:** CONTACT

**Contact 2:**

**Email:** mohamed.tarek67@dent.menofia.edu.eg

**Name:** Mohammed T. Khater, PhD

**Phone:** 01003854552

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mansoura

**Contacts:**

***Contact 1:***

- **Email:** Dr_sawy@windowslive.com

- **Name:** Mohammed A. El-Sawy

- **Phone:** 161314522

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Mohammed A. El-Sawy

**Status:** RECRUITING

**Zip:** 12345

#### Overall Officials

**Official 1:**

**Affiliation:** Menoufia University

**Name:** Mohammed A. El-Sawy, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** The result can be shared upon request from the corresponding author

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14338

- Name: Prosthesis Failure

- Relevance: HIGH

- As Found: Prosthesis Survival

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011475

- Term: Prosthesis Failure

### Misc Info Module

- Version Holder: 2024-05-31
