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

Maxillofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05713084
• Other study ID #: 14922
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: September 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class III
• Maxillofacial Abnormalities
• Prognathism
• Skeletal Malocclusion

Intervention

Other:
• mandibular setback using BSSRO
mandibular setback using BSSRO

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical assessment of maximum incisal opening (MIO)	assessment of changes(in millimetre) in Maximum incisal opening (MIO)	Preoperative - 1 months postoperative - 6 months postoperative
Other	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
Other	sounds on TMJ	assessment of resulted sounds during TMJ function (present or not present)	Preoperative - 1 months postoperative - 6 months postoperative
Primary	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	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