Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia

Not Applicable

Not yet recruiting

• Conditions: Maxillary Hypoplasia; Cleft Lip Palate; Orthognathic Surgery

• Registration Number: NCT06852196
• Lead Sponsor: Assiut University

Brief Summary

Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, Midfacial hypoplasia is commonly treated by performing conventional Le Fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. .

Midface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. Intraoral findings are anterior and posterior crossbite, CLP, accentuated curve of Spee, Class III dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. Speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study Start: 2025-02-21
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-09-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Cleft patients either cleft alveolus or cleft alveolus and palate.
• Surgically fit patients.
• Patients ready for orthognathic assessment undergoing either surgical or orthodontics correction.

Exclusion Criteria

• Non- cleft cases .
• Previous correction.
• History of active infection or underlying disease such as hematologic disorders neoplasm, and immune deficiency.
• Patient refused to sign an informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CEPHALOMETRIC	1 year	MAXILLARY COMPONENT SNA (degrees) Sella to Nasion to point A angle normal angle is 82 degree plus or minus 3 degree

Secondary Outcome Measures

Name	Time	Method
facial canons	1 year	the rule of fifths, which divides the face in the transverse dimension into five equal parts by assuming that the intercanthal distance is equal to the nasal width and widths of the eyes, incorporates orbital and orbito-nasal canons; and three equal lengths of the face (the forehead, the nose, and the mouth and chin), as well as the intercanthal distance being equal to the eye fissure length measurement are in cm