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出境医 / 临床实验 / Condylar Segment Repositioning Using CAD/CAM Generated Wafer After BSSO in Skeletal Mandibular Deformity

Condylar Segment Repositioning Using CAD/CAM Generated Wafer After BSSO in Skeletal Mandibular Deformity

Study Description
Brief 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


Condition or disease Intervention/treatment Phase
Skeletal Abnormalities Other: Bilateral Sagittal Split Osteotomy Not Applicable

Detailed 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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020
Arms and Interventions
Arm Intervention/treatment
computer guided condylar reposition device
surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device
 Other: Bilateral Sagittal Split Osteotomy
after BSSO condyle will be re positioned by using computer guided device
Outcome Measures
Primary Outcome Measures :
  1. accuracy of postoperative condylar position in relation to the corrected virtual model [ Time Frame: immediate postoperative ]
    the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)


Secondary Outcome Measures :
  1. operative time [ Time Frame: during operation ]
    surgical time will be assessed via clinical assessment measuring unit (hours)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
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Contact: yara mamdouh mustafa, BDS 01002955632 yara.mustafa@dentistry.cu.edu.eg
Contact: yara mamdouh mustafa, BDS 0100295532 yara.mustafa@dentistry.cu.edu.eg

Locations
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Egypt
oral and dental medicine Cairo university Recruiting
Giza, Egypt, 12613
Contact: yara mamdouh, BDS    01002955632    yara.mustafa@dentistry.cu.edu.eg   
Contact: Mohammed omara, PHD    01144452862    omara_mohammed@ymail.com   
Principal Investigator: Mohammed omara, Lecturer         
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Mohammed omara, Lecturer faculty of oral and dental medicine Cairo university
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE November 20, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		accuracy of postoperative condylar position in relation to the corrected virtual model [ Time Frame: immediate postoperative ]
the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		operative time [ Time Frame: during operation ]
surgical time will be assessed via clinical assessment measuring unit (hours)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Condylar Segment Repositioning Using CAD/CAM Generated Wafer After BSSO in Skeletal Mandibular Deformity
Official Title  ICMJE Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
Brief 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
Detailed 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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Skeletal Abnormalities
Intervention  ICMJE Other: Bilateral Sagittal Split Osteotomy
after BSSO condyle will be re positioned by using computer guided device
Study Arms  ICMJE computer guided condylar reposition device
surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device
Intervention: Other: Bilateral Sagittal Split Osteotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983265
Other Study ID Numbers  ICMJE ymmustafa
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party yara mamdouh mustafa, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohammed omara, Lecturer faculty of oral and dental medicine Cairo university
PRS Account Cairo University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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