Bone Augmentation Using Calvarial Versus Iliac Crest Bone Blocks.

NCT ID: NCT06434441

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2025-03-01

Brief Summary

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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

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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

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Bone Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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,
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Masking in not applicable for the patients or the operators

Study Groups

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Study group:

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

Group Type ACTIVE_COMPARATOR

Autogenous bone augmentation

Intervention Type PROCEDURE

Maxillary alveolar bone reconstruction

Control group:

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

Group Type ACTIVE_COMPARATOR

Autogenous bone augmentation

Intervention Type PROCEDURE

Maxillary alveolar bone reconstruction

Interventions

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Autogenous bone augmentation

Maxillary alveolar bone reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Amr Gibaly

Associate Professor of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amr Gibaly

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr Gibaly

Role: CONTACT

01113336634

Facility Contacts

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Amr Gibaly

Role: primary

01113336634

Other Identifiers

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13

Identifier Type: -

Identifier Source: org_study_id

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