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

Primary Purpose

Maxillofacial Abnormalities, Mandible Prognathism, Skeletal Malocclusion

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mandibular setback using BSSRO
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillofacial Abnormalities focused on measuring mandibular setback, low medial cut, condylar position

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Dentistry Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mandibular setback using low medial cut ostetomy

mandibular setback using high medial cut ostetomy

Arm 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.

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 ,

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 21, 2023
Last Updated
February 2, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05713084
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Abnormalities, Mandible Prognathism, Skeletal Malocclusion
Keywords
mandibular setback, low medial cut, condylar position

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mandibular setback using low medial cut ostetomy
Arm Type
Experimental
Arm 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.
Arm Title
mandibular setback using high medial cut ostetomy
Arm Type
Active Comparator
Arm 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 ,
Intervention Type
Other
Intervention Name(s)
mandibular setback using BSSRO
Intervention Description
mandibular setback using BSSRO
Primary Outcome Measure Information:
Title
3D mandibular condylar position changes
Description
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
Time Frame
Preoperative- 1-month postoperative - 6 months post operative
Secondary Outcome Measure Information:
Title
Assessment of changes in articular disc position
Description
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.
Time Frame
Preoperative , 6month postoperative
Other Pre-specified Outcome Measures:
Title
Clinical assessment of maximum incisal opening (MIO)
Description
assessment of changes(in millimetre) in Maximum incisal opening (MIO)
Time Frame
Preoperative - 1 months postoperative - 6 months postoperative
Title
pain on TMJ
Description
assessment of changes in severity of pain over TMJ using (pain scale from 0 to 10)
Time Frame
Preoperative - 1 months postoperative - 6 months postoperative
Title
sounds on TMJ
Description
assessment of resulted sounds during TMJ function (present or not present)
Time Frame
Preoperative - 1 months postoperative - 6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahmy Mobarak, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry Cairo University
City
Cairo
ZIP/Postal Code
11553
Country
Egypt

12. IPD Sharing Statement

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

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