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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Alveolar Cleft

Treatments: Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT06523855

4623358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

Experimental group

Description:

in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect, 8-hole microplates will be used to fix the premaxilla using screws. The microplates are to be removed 6 to 9 months postoperatively.

Treatment:

Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation

bilateral alveolar cleft grafting using iliac crest particulate

Active Comparator group

Description:

in bilateral alveolar cleft, the cancellous particulate bone graft from anterior iliac crest will be used to fill the defect.

Treatment:

Procedure: bilateral alveolar cleft grafting using iliac crest particulate and microplate fixation