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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03983265
Other study ID # ymmustafa
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date January 2020

Study information

Verified date June 2019
Source Cairo University
Contact yara mamdouh mustafa, BDS
Phone 01002955632
Email yara.mustafa@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Maintaining the condylar position after bilateral sagittal split ramus osteotomy (BSSO) is one of the most important aspects in terms of condylar function ,.An altered condylar position can cause internal derangement of the joint, loss of the mandibular angle, increased risk of relapse, condyle sagging, and impaired masticatory function.

In previous years, a great deal of attention has been paid to maintaining the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported and could be divided into manual/empirical methods, conventional methods , navigation, and sonographic monitoring, Computer guided methods which is more accurate than other methods


Description:

unpredictable condylar position after orthognathic surgery, will lead to malocclusion, derangement of the condylar surface, condylar resorption, condylar sag, distraction of the condyles from the fosse. In previous years, several authors had been adopted several techniques to maintain the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported which could be divided into conventional techniques (manual maneuvers or aiding tools), Extra and intra oral navigational techniques , surgeons had been utilized these techniques in condylar repositiong after BSSO but it was time and effort consuming and sometimes it was inaccurate. the aim for conducting the research is accurate positioning of condyle three dimensionally to minimize effort and operating time of surgery .


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Age of the patient above 18 years

- Patients needs bilateral sagittal split osteotomy

- All patients are free from any systemic disease that may affect normal bone healing

- Sufficient dentition to reproduce the occlusal relationships

- Patient's consent to participate

Exclusion Criteria:

- Patient with TMJ Disorders

- Patients with any systemic disease that may affect normal healing

- Intra-bony lesions or infections that may interfere with surgery.the presence of

- Previous orthognathic surgeries

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bilateral Sagittal Split Osteotomy
after BSSO condyle will be re positioned by using computer guided device

Locations

Country Name City State
Egypt oral and dental medicine Cairo university Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy of postoperative condylar position in relation to the corrected virtual model the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm) immediate postoperative
Secondary operative time surgical time will be assessed via clinical assessment measuring unit (hours) during operation
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