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

NCT05283005 | Unknown

• 1 other identifier: 29-12-21
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Cleft

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Measuring graft volume in cubic millimeter

  9 months

Study Arms (2)

alveolar cleft patients will be treated by conventional technique

ACTIVE COMPARATOR

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

Procedure: Grafting of the alveolar cleft

alveolar cleft patients will be treated by double cortex technique

EXPERIMENTAL

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

Procedure: Grafting of the alveolar cleft

Interventions

Grafting of the alveolar cleft PROCEDURE

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

alveolar cleft patients will be treated by conventional technique; alveolar cleft patients will be treated by double cortex technique

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, Cairo university

Cairo, Egypt

RECRUITING

Central Study Contacts

Louai A Raafat, BDS

CONTACT

00201142904383; louai.raafat@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 16, 2022
• Study Start: December 28, 2021
• Primary Completion: December 29, 2022
• Study Completion: December 31, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

EG (1)