Partial Maxillary Expansion With Post Grafting Expansion vs. Pre Full Maxillary Expansion in Secondary Alveolar Cleft

Study Overview
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Brief Summary
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Intermediate grafting with both pre- and post- grafting maxillary expansion with time span after grafting 6-8 weeks for consolidation and final retention for 3 months after finalization of expansion will get the advantages of both techniques combined.

Detailed Description
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Secondary alveolar bone grafting (SABG) is an essential step in the overall management of Patients with cleft lip and palate (CLP). The numerous advantages of this procedure have been reported in the literature. However, resorption of the bone graft is a common situation, and the success of alveolar bone grafting (ABG) depends on several factors . The periodontal health of the surrounding graft tissues, the experience and ability of the surgeon and the timing of surgery are shown to be the most important factors determining success. Failure to rehabilitate the alveolar cleft may give rise to a variety of problems, including oronasal fistula, fluid reflux, speech pathology, impaired tooth eruption, lack of bone support for the anterior teeth, dental crowding, periodontal recession and eventual loss of teeth, and maxillary and facial asymmetry . Lack of alveolar bone also limits orthodontic treatment and/or prosthodontics rehabilitation. Post graft stimulation of maturation through remodeling of the graft is extremely important and is provided primarily by natural tooth eruption. Thus, the ideal time period for SABG is shown as to be the mixed dentition stage (9-12 years), just before the eruption of the permanent canine in line with the cleft. Timing of maxillary expansion in patients with cleft lip and palate is debated. Proponents of expanding the maxilla prior to secondary alveolar bone grafting state it is beneficial to align the segments prior to bone grafting better access for placement of the graft and working facility during surgery, However more recent literature shows maxillary expansion after secondary bone grafting is possible Advocates of expansion following grafting cite the advantages that bone consolidation is improved when the graft is placed under a dynamic load during healing and that there is a smaller soft tissue defect to close, less difficulty procuring an adequate volume of bone, and a narrower defect, which will regenerate bone more quickly and less possibility to induce oronasal fistula during maxillary expansion the study will change the concept of alveolar bone grafting in relation to maxillary expansion .just getting 5 mm minimal between two cleft edges and 2/3 of canine or lateral root has been formed and thin bone separate tooth from cleft defect the graft could be done

Official Title
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The Effect of Pre Grafting Partial Maxillary Expansion With Post Grafting Expansion Versus Pre Grafting Full Maxillary Expansion on the Stability and Bone Resorption in Secondary Unilateral Alveolar Cleft Grafting

Conditions
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Alveolar Cleft

Intervention / Treatment
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* Procedure: pre grafting partial maxillary expansion with post grafting expansion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral cleft alveolus with in the mixed dentition stage No intraoral soft and hard tissue pathology No systemic condition that contraindicate grafting Exclusion Criteria: Local criteria: poor oral hygiene radiation therapy the head and neck cancers Systemic criteria: immunity deficiency or hemorrhagic inherited diseases Bone pathology

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre grafting partial maxillary expansion with post grafting expansion<br>pregrafting partial maxillary expansion then grafting left bone to consolidate for 2 months followed by post grafting expansion till full arch alignment | Procedure: pre grafting partial maxillary expansion with post grafting expansion<br>* pre grafting partial maxillary expansion then anterior iliac grafting followed by 2 months period for consolidation then post grafting expansion till full arch alignment<br>|
| Active Comparator: pre grafting full maxillary expansion<br>pre grafting full maxillary expansion till full arch alignment then grafting and let bone to consolidate | Procedure: pre grafting partial maxillary expansion with post grafting expansion<br>* pre grafting partial maxillary expansion then anterior iliac grafting followed by 2 months period for consolidation then post grafting expansion till full arch alignment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone volume change | bone volume is measured to ensure successful grafting | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of relapse of expansion | detection of any relapse after removal of maxillary expanders | 8 months |