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

Alveolar Cleft Reconstruction Using Double Iliac Corticocancellous Bone Blocks Technique Versus Particulate Autogenous Spongy Bone Graft From Anterior Iliac Crest. A Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Alveolar Cleft
• Intervention / Treatment: Procedure: Grafting of the alveolar cleft

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louai A Raafat, BDS; Phone Number: 00201142904383; Email: louai.raafat@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry, Cairo University
    • Contact: Mohammed A Omara, PhD; Phone Number: 00201144452862

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Grafting of the alveolar cleft; alveolar cleft grafting using either the conventional technique or the double cortex technique
Experimental: 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.	Procedure: Grafting of the alveolar cleft; alveolar cleft grafting using either the conventional technique or the double cortex technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring graft height in millimeters	CBCT scan analysis for measuring mean graft height in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft height in millimeters after 9 months of every graft for assessment of grafts height stability of both groups over 9 months.	9 months
Measuring graft width in millimeters	CBCT scan analysis for measuring mean graft width in millimeters of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring mean graft width in millimeters after 9 months of every graft for assessment of grafts width stability of both groups over 9 months.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring graft volume in cubic millimeter	CBCT scan analysis for measuring graft volume in cubic millimeter of every graft of both groups of patients immediately after surgery and compare it with CBCT scan analysis for measuring graft volume in cubic millimeter after 9 months of every graft for assessment of grafts volume stability of both groups over 9 months.	9 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Anticipated): December 29, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 29-12-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No