Alveolar Cleft Grafting by Double Iliac Bone Blocks Versus Iliac Spongy Bone From Anterior Iliac Crest

NCT ID: NCT05283005

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2022-12-31

Brief Summary

Reconstruction of Alveolar Cleft Using Double Iliac Corticocancellous Blocks in comparison with the gold standard technique ( cancellous bone ) both from anterior iliac crest.

Detailed Description

This study will compare two techniques for the proper alveolar cleft reconstruction with adequate bone bridge formation of maximum bone quality, contour, and minimal resorption. One of them is packing autogenous particulate spongy bone from the anterior iliac crest (gold standard). While the other technique would be reconstruction of the cleft with two iliac corticocancellous bone blocks with cancellous bone in between. which benefits of the rapid revascularization and healing of cancellous bone and the strong mechanical properties of cortical bone that will aid in obtaining a proper reconstruction and form for the defect and can be applied to defects of any size.

Conditions

Alveolar Cleft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

alveolar cleft patients will be treated by conventional technique

Reconstruction of alveolar cleft by autogenous cancellous bone from the anterior iliac crest (gold standard technique).

Group Type: ACTIVE_COMPARATOR

Grafting of the alveolar cleft

Intervention Type: PROCEDURE

alveolar cleft grafting using either the conventional technique or the double cortex technique

alveolar cleft patients will be treated by double cortex technique

Reconstruction of alveolar cleft by autogenous double iliac cortico-cancellous bone blocks from the anterior iliac crest.

Group Type: EXPERIMENTAL

Grafting of the alveolar cleft

Intervention Type: PROCEDURE

alveolar cleft grafting using either the conventional technique or the double cortex technique

Interventions

Grafting of the alveolar cleft

alveolar cleft grafting using either the conventional technique or the double cortex technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with complete maxillary alveolar cleft either unilateral or bilateral at the age of mixed dentition (between 7 and 13 years old).

• repaired cleft lip.
• Patients with cleft lip and palate who have not undergone alveolar grafting procedure.
• Patients with unerupted maxillary permanent canine in the cleft region.
• Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
• Both genders males and females will be included

Exclusion Criteria

• General contraindications to surgical intervention of the area. Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft.

• Patients with associated syndrome.
• Patients requiring concomitant Orthognathic surgical procedure.
• Subjected to irradiation in the head and neck area less than 1 year before surgery.
• Untreated periodontitis.
• Poor oral hygiene.
• Uncontrolled diabetes.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Active infection or severe inflammation in the area intended for graft placement.
• Patients participating in other studies, if the present protocol could not be properly followed.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Louai Ahmed Rafat Mohammed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of dentistry, Cairo university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Louai A Raafat, BDS

Role: CONTACT

louai.raafat@dentistry.cu.edu.eg

00201142904383

Facility Contacts

Mohammed A Omara, PhD

Role: primary

00201144452862

Other Identifiers

29-12-21

Identifier Type: -

Identifier Source: org_study_id