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

Assessment of Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial vs High Medial Cut (Randomized Controlled Trial)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Maxillofacial Abnormalities; Skeletal Malocclusion; Mandible Prognathism
• Intervention / Treatment: Other: mandibular setback using BSSRO

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mandibular setback using low medial cut ostetomy; 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 BSSRO
ACTIVE_COMPARATOR: mandibular setback using high medial cut ostetomy; 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; mandibular setback using BSSRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D mandibular condylar position changes	assessment of condylar position changes in millimetre using C.T.(axial ,coronal and sagital cut. ).; Axial condylar head long-axis angle (AHA):angle between the sagittal plane and the axial condylar head axis line; Axial condylar head position (AHP):perpendicular distance between the sagittal plane and the most medial point of the condylar head; Frontal condylar head long-axis angle (FHA):angle between the axial plane and the frontal condylar head long-axis line; Frontal condylar head position (FHP):perpendicular distance between the axial plane and most superior point of the condylar head; Sagittal condylar head long-axis angle (SHA):angle between the coronal plane and the sagittal condylar head long-axis line; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in articular disc position	In order to trace the position of the TMJ disc, a line was drawn from the uppermost point of the articular fossa (UAF, marked as 10) to the lowermost point of the articular tubercle (LAT, marked as 0). This line was continued anteriorly and inferiorly. If the anterior border of the disc was anterior to this line, it was considered negative. These two points were chosen because they did not change with remodelling . Perpendicular lines to this line were drawn in the anterior and posterior borders of the disc. Finally, disc position was determined by averaging anterior (point A) and posterior (point P) disc limits.	Preoperative , 6month postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of maximum incisal opening (MIO)	assessment of changes(in millimetre) in Maximum incisal opening (MIO)	Preoperative - 1 months postoperative - 6 months postoperative
pain on TMJ	assessment of changes in severity of pain over TMJ using (pain scale from 0 to 10)	Preoperative - 1 months postoperative - 6 months postoperative
sounds on TMJ	assessment of resulted sounds during TMJ function (present or not present)	Preoperative - 1 months postoperative - 6 months postoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Fahmy Mobarak, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: mandibular setback; low medial cut; condylar position
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Maxillofacial Abnormalities; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: 14922

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No