## Protocol Section
### Identification Module
**NCT ID:** NCT06434441

**Brief Title:** Bone Augmentation Using Calvarial Versus Iliac Crest Bone Blocks.

**Official Title:** Radiographic Assessment of Horizontal Bone Augmentation of Full Atrophic Maxillary Alveolar Ridges Using Calvarial Versus Iliac Crest Bone Blocks:

#### Organization Study ID Info
**ID:** 13
#### Organization
**Class:** OTHER
**Full Name:** Beni-Suef University
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-08-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beni-Suef University

#### Responsible Party

**Investigator Affiliation:** Beni-Suef University

**Investigator Full Name:** Amr Gibaly

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

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones

**Detailed Description:** Although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft.

The anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. However, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. Pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation.

This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones.

### Conditions Module

**Conditions:**

- Bone Atrophy

**Keywords:**

- Bone graft

- Iliac crest blocks

- Calverial bone blocks

- Horizontal bone gain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** A) The Study group:

The patients within the study group will receive mono-cortical bone block calvarial grafts

B) The Control group:

The patients within the control group will receive mono-cortical bone block iliac crest grafts,

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Masking in not applicable for the patients or the operators

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients will receive calverial grafts, to reconstruct the deficient maxillary ridge

**Intervention Names:**

- Procedure: Autogenous bone augmentation

**Label:** Study group:

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The patients will receive iliac crestgrafts, to reconstruct the deficient maxillary ridge

**Intervention Names:**

- Procedure: Autogenous bone augmentation

**Label:** Control group:

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group:

- Study group:

**Description:** Maxillary alveolar bone reconstruction

**Name:** Autogenous bone augmentation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** the study compares the horizontal bone gain of reconstructed maxillary alveolar ridges after being augmented with calverial and iliac crest bone grafts radiographically by millimeters

**Measure:** Horizontal bone gain

**Time Frame:** 6 months consolidation period

#### Secondary Outcomes

**Description:** the study compares the bone area percent of the consolidated calverial and iliac crest bone grafts

**Measure:** Immunohistochemical bone formation

**Time Frame:** 6 months consolidation period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm

Exclusion Criteria:

* Any previous maxillary reconstructive or dental implant treatment.
* Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.

**Maximum Age:** 55 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** amrgibaly@dent.bsu.edu.eg

**Name:** Amr Gibaly

**Phone:** 01113336634

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** amrgibaly@dent.bsu.edu.eg

- **Name:** Amr Gibaly

- **Phone:** 01113336634

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Amr Gibaly

**Status:** RECRUITING

**Zip:** 62764

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4589

- Name: Atrophy

- Relevance: HIGH

- As Found: Atrophy

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001284

- Term: Atrophy

### Misc Info Module

- Version Holder: 2024-05-31
