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

NCT05713084 | Unknown DMC

• 1 other identifier: 14922
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maxillofacial Abnormalities; Mandible Prognathism; Skeletal Malocclusion

Keywords

mandibular setback; low medial cut; condylar position

Outcome Measures

Primary Outcomes (1)

• 3D mandibular condylar position changes

  assessment of condylar position changes in millimetre using C.T.(axial ,coronal and sagital cut. ). 1. Axial condylar head long-axis angle (AHA): angle between the sagittal plane and the axial condylar head axis line 2. Axial condylar head position (AHP): perpendicular distance between the sagittal plane and the most medial point of the condylar head 3. Frontal condylar head long-axis angle (FHA): angle between the axial plane and the frontal condylar head long-axis line 4. Frontal condylar head position (FHP): perpendicular distance between the axial plane and most superior point of the condylar head 5. Sagittal condylar head long-axis angle (SHA): angle between the coronal plane and the sagittal condylar head long-axis line 6. Sagital condylar head position (SHP): perpendicular distance between the coronal plane and the most superior point of the condylar head

  Preoperative- 1-month postoperative - 6 months post operative

Secondary Outcomes (1)

• Assessment of changes in articular disc position

  Preoperative , 6month postoperative

Other Outcomes (3)

• Clinical assessment of maximum incisal opening (MIO)

  Preoperative - 1 months postoperative - 6 months postoperative

• pain on TMJ

  Preoperative - 1 months postoperative - 6 months postoperative

• sounds on TMJ

  Preoperative - 1 months postoperative - 6 months postoperative

Study Arms (2)

mandibular setback using low medial cut ostetomy

EXPERIMENTAL

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.

Other: mandibular setback using BSSRO

mandibular setback using high medial cut ostetomy

ACTIVE COMPARATOR

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 ,

Other: mandibular setback using BSSRO

Interventions

mandibular setback using BSSRO OTHER

mandibular setback using BSSRO

mandibular setback using high medial cut ostetomy; mandibular setback using low medial cut ostetomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Maxillofacial Abnormalities; Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malocclusion; Tooth Diseases

Study Officials

• Fahmy Mobarak, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: February 6, 2023
• Study Start: September 28, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

EG (1)