## Protocol Section
### Identification Module
**NCT ID:** NCT06416605

**Brief Title:** Autogenous Tooth Graft for Ridge Augmentation

**Official Title:** Tooth Shell Versus Bone Shell Technique For Horizontal Maxillary Alveolar Ridge Augmentation

#### Organization Study ID Info
**ID:** A03030123
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-01-01

**Type:** ACTUAL

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

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Investigator Affiliation:** Mansoura University

**Investigator Full Name:** Heba Elsheikh

**Investigator Title:** Assistant Professor of Oral and Maxillofacial Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft.

**Detailed Description:** twenty eight patients with one or two maxillary extracted teeth in need for horizontal bone augmentation and implant placement will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University patients will be divided into two equal groups:

• Group I: Horizontal bone augmentation will be done by bone shell technique.

• Group II: Horizontal bone augmentation will be done by autogenous tooth shell technique.

Evaluation:

A-Clinical evaluation:

* All patients were followed up on a weekly basis for the first postoperative month, then monthly for the rest of the postoperative period (6months) until implantation.
* The patients were evaluated regarding pain, edema and hematoma at recipient and donor sites as well as healing of the mucosa.
* A neurosensory evaluation was carried out at each clinical check up by asking the patient if there were any areas of hypoesthesia, numbness or tingling in the lower lip and chin at the side of the donor site.

B-Radiographic evaluation

•Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement. According to the measurements obtained from CBCT, appropriate implant size and length will be chosen and placed 6 months postoperative after removal of the micro screws.

Radiographic analysis:

Linear measurements of alveolar bone width were taken using CBCT scan at three stages; prior to grafting (T0) and immediately (T1), and 4 months post grafting (T2). Then three horizontal alveolar width measurements (crestal, middle and apical) were recorded at T0, T2 and T1. The measurement was performed with fixed points each time, the buccolingual width was measured at different levels. At the bone crest, 3mm from the bone crest and 6mm from the bone crest. The measurements were tabulated for statistical analysis.

### Conditions Module

**Conditions:**

- Dental Implant

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Horizontal bone augmentation will be done by bone shell technique

**Intervention Names:**

- Procedure: Maxillary Alveolar Ridge Augmentation

**Label:** group A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Horizontal bone augmentation will be done by autogenous tooth shell technique

**Intervention Names:**

- Procedure: Maxillary Alveolar Ridge Augmentation

**Label:** group B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- group A

- group B

**Description:** using tooth graft or bone graft to increase alveolar ridge width to be able to insert dental implant

**Name:** Maxillary Alveolar Ridge Augmentation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement.

**Measure:** horizontal alveolar width measurements

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- 1- One or two maxillary extracted teeth with crestal bone width of 4 mm or less.

2- Age ranging from 18_50 years 3- 3- Adequate oral hygiene. 4- Non smoking patients. 5-Free from any pathological lesions related to the tooth to be extracted. 6- Physically fit to withstand the whole procedure.

Exclusion Criteria:

* 1- Active infection in the site to be treated. 2- Patients on chemotherapy or radiotherapy. 3- Alcohol or drug abuse. 4- Patients who have systemic disorders that interfere with bone healing {uncontrolled diabetes mellitus, autoimmune disease,

  * etc.} 5- Pregnancy. 6- Patients with bone disease. 7- Patients with parafunctional habits

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mansoura

**Country:** Egypt

**Facility:** Heba Elsheikh

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
