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

Not Applicable

Not yet recruiting

• Conditions: Alveolar Cleft
• Interventions: Procedure: pre grafting partial maxillary expansion with post grafting expansion

• Registration Number: NCT05941988
• Lead Sponsor: Cairo University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2023-06-11
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18
• Study Start: 2023-09-20
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• Local criteria:

  • poor oral hygiene
  • radiation therapy the head and neck cancers

Systemic criteria:

• immunity deficiency or hemorrhagic inherited diseases
• Bone pathology

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre grafting partial maxillary expansion with post grafting expansion	pre grafting partial maxillary expansion with post grafting expansion	pregrafting partial maxillary expansion then grafting left bone to consolidate for 2 months followed by post grafting expansion till full arch alignment
pre grafting full maxillary expansion	pre grafting partial maxillary expansion with post grafting expansion	pre grafting full maxillary expansion till full arch alignment then grafting and let bone to consolidate

Primary Outcome Measures

Name	Time	Method
Bone volume change	6 months	bone volume is measured to ensure successful grafting

Secondary Outcome Measures

Name	Time	Method
presence of relapse of expansion	8 months	detection of any relapse after removal of maxillary expanders