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Clinical Trials/NCT06585566
NCT06585566
Recruiting
Not Applicable

Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)

Beni-Suef University2 sites in 1 country10 target enrollmentOctober 4, 2024
ConditionsAlveolar Cleft

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Cleft
Sponsor
Beni-Suef University
Enrollment
10
Locations
2
Primary Endpoint
Horizontal bone width
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.

The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.

Registry
clinicaltrials.gov
Start Date
October 4, 2024
End Date
October 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Gibaly

Associate Professor of Oral and Maxillofacial Surgery

Beni-Suef University

Eligibility Criteria

Inclusion Criteria

  • Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
  • good oral hygiene and general good health

Exclusion Criteria

  • The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
  • Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
  • A history of previous failed alveolar cleft reconstruction.

Outcomes

Primary Outcomes

Horizontal bone width

Time Frame: 6 months consolidation period

The amplitude of radiographic horizontal bone width change

Secondary Outcomes

  • Vertical bone level(6 months consolidation period)
  • Bone density(6 months consolidation period)

Study Sites (2)

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