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

Assiut University

Status: Not yet enrolling

Conditions: Cleft Lip Palate; Maxillary Hypoplasia; Orthognathic Surgery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06852196

Cleft Maxillary Hypoplasia

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

surgery first

Experimental group

Description:

modern surgery-first orthognathic surgery approach (reduced treatment time, efficient tooth decompensation, and early improvement in facial esthetics),

Treatment:

Procedure: distraction osteogenesis

Procedure: orthognathic surgery ,lefort 1,bsso ,DO

othodontics first

Experimental group

Description:

orthodontics first then surgery

Treatment:

Procedure: distraction osteogenesis

Procedure: orthognathic surgery ,lefort 1,bsso ,DO