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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthognathic Surgery; Maxillary Hypoplasia; Cleft Lip Palate
• Intervention / Treatment: Procedure: orthognathic surgery ,lefort 1,bsso ,DO; Procedure: distraction osteogenesis

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgery first; modern surgery-first orthognathic surgery approach (reduced treatment time, efficient tooth decompensation, and early improvement in facial esthetics),	Procedure: orthognathic surgery ,lefort 1,bsso ,DO; Le Fort I osteotomy is often used in the correction of dental occlusion and maxillary hypoplasia in cleft patients. In addition, the osteotomy may also improve patients' facial appearance and self-esteem; Procedure: distraction osteogenesis; Distraction osteogenesis is a surgical technique that uses body's own repairing mechanisms for optimal reconstruction of the tissues.
Experimental: othodontics first; orthodontics first then surgery	Procedure: orthognathic surgery ,lefort 1,bsso ,DO; Le Fort I osteotomy is often used in the correction of dental occlusion and maxillary hypoplasia in cleft patients. In addition, the osteotomy may also improve patients' facial appearance and self-esteem; Procedure: distraction osteogenesis; Distraction osteogenesis is a surgical technique that uses body's own repairing mechanisms for optimal reconstruction of the tissues.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
facial canons	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	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): February 21, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cleft maxillary hypoplasia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Micrognathism; Cleft Lip
• Other Study ID Numbers: Cleft Maxillary Hypoplasia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No