Clinical trial NCT05713084: Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial Cut.
Official title: Assessment of Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial vs High Medial Cut (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillofacial Abnormalities
Mandible Prognathism
Skeletal Malocclusion
Keywords: mandibular setback
low medial cut
condylar position
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3D mandibular condylar position changes
timeFrame: Preoperative- 1-month postoperative - 6 months post operative
Secondary outcomes:
measure: Assessment of changes in articular disc position
timeFrame: Preoperative , 6month postoperative
Other outcomes:
measure: Clinical assessment of maximum incisal opening (MIO)
timeFrame: Preoperative - 1 months postoperative - 6 months postoperative
measure: pain on TMJ
timeFrame: Preoperative - 1 months postoperative - 6 months postoperative
measure: sounds on TMJ
timeFrame: Preoperative - 1 months postoperative - 6 months postoperative
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
affiliation: Cairo University
name: Fahmy Mobarak, professor
role: STUDY_DIRECTOR
References: