Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial Cut.

Cairo University (CU)

Status: Active, not recruiting

Conditions: Mandible Prognathism; Maxillofacial Abnormalities; Skeletal Malocclusion

Treatments: Other: mandibular setback using BSSRO

Study type: Interventional

Funder types: Other

Identifiers

NCT05713084

14922

Details and patient eligibility

About

This study hypotheses that using low medial cut osteotomy BSSO in mandibular setback can be an efficient and effective method to limit the bony segment interferences , decreasing muscles stripping during osteotomy ,decrease condylar torque and so securing preoperative condylar position during BSSO in comparison with using high medial cut BSSO.

Full description

Research question:

Description of research question:

P: Population: Patients with facial skeletal deformity and need for mandibular setback using bilateral sagittal split osteotomy (BSSRO) alone or combined with lefort osteotomy.

I: Intervention: Patients with facial skeletal deformity and need and for mandibular setback using low medial cut osteotomy as modification of bilateral sagittal split ramus osteotomy (BSSRO).

C: Comparator: Patients with facial skeletal deformity and need and for mandibular setback using traditional high medial cut osteotomy bilateral sagittal split ramus osteotomy (BSSRO).

O: Outcome: Comparing the post-operative condylar positions changes and TMJ functions of two osteotomies.

Research question:

Is using low medial cut osteotomy modification in BSSRO in mandibular setback will provide more control over proximal segment position than traditional high medial cut through:

1. limit the segments interference and so maximizes the passive bony contact across the osteotomy site after surgically repositioning the distal segment
2. Passively positioned the proximal segment without displacement of the condyle from its normal position.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age of the patient between (18-60) years
• Patients in need of mandibular setback using bilateral sagittal split osteotomy.
• All patients are free from any systemic disease that may affect normal bone healing.
• Patient with facial deformity will be treated with mandibular setback either mono or bimaxilary surgeries
• Patient with facial deformity will be treated with mandibular setback either surgery first approach or orthofirst approach.
• Sufficient dentition to reproduce the occlusal relationships
• Patient's consent to participate

Exclusion criteria

• Patients with any systemic disease that may affect normal healing
• Intra-bony lesions or infections that may interfere with surgery.
• Previous orthognathic surgeries.
• Patients with all types of facial clefts

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

mandibular setback using low medial cut ostetomy

Experimental group

Description:

mandibular setback using low medial cut ostetomy by keeping the cut ''low'' or close to the mandibular occlusal plane and ''short'' or terminating anterior to the lingula.

Treatment:

Other: mandibular setback using BSSRO

mandibular setback using high medial cut ostetomy

Active Comparator group

Description:

mandibular setback by placement of the medial ramus osteotomy cut 'high', just a few millimeters above the lingula, superior and lateral to the entrance point of the inferior alveolar nerve (IAN) into the mandibular foramen ,

Treatment:

Other: mandibular setback using BSSRO