Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique

Not Applicable

Not yet recruiting

• Conditions: Alveolar Cleft

• Registration Number: NCT06523855
• Lead Sponsor: Cairo University

Brief Summary

The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.

Detailed Description

In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula.

In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study Start: 2024-07-24
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-01-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
• repaired cleft lip.
• 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 unilateral maxillary alveolar cleft.
• Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
• 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.
• Active infection or severe inflammation in the area intended for graft placement
• Unable to open mouth sufficiently to accommodate the surgical tooling.
• Patients participating in other studies, if the present protocol could not be properly followed.
• Unable to attend a 9-month follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bone density immediate versus 6 months postoperatively.	6 months	bone density changes are measured using CBCT after 6 months via HU

Secondary Outcome Measures

Name	Time	Method
Bone width and height immediate versus 6 months postoperatively	6 months	bone height and width changes are measured using CBCT after 6 months in mm

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo university; 🇪🇬 Cairo, Egypt