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

NCT06852196 | Not Yet Recruiting DMC

• 1 other identifier: Cleft Maxillary Hypoplasia
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maxillary Hypoplasia; Cleft Lip Palate; Orthognathic Surgery

Keywords

cleft maxillary hypoplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• facial canons

  1 year

Study Arms (2)

surgery first

EXPERIMENTAL

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; Procedure: distraction osteogenesis

othodontics first

EXPERIMENTAL

orthodontics first then surgery

Procedure: orthognathic surgery ,lefort 1,bsso ,DO; Procedure: distraction osteogenesis

Interventions

orthognathic surgery ,lefort 1,bsso ,DO PROCEDURE

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

othodontics first; surgery first

distraction osteogenesis PROCEDURE

Distraction osteogenesis is a surgical technique that uses body's own repairing mechanisms for optimal reconstruction of the tissues.

othodontics first; surgery first

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Retrognathia

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of plastic surgery

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02