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

Alveolar Cleft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283005
• Other study ID #: 29-12-21
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Louai A Raafat, BDS
• Phone: 00201142904383
• Email: louai.raafat[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 31, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Cleft

Intervention

Procedure:
• Grafting of the alveolar cleft
alveolar cleft grafting using either the conventional technique or the double cortex technique

Locations

Country	Name	City	State
Egypt	Faculty of dentistry, Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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