Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
Primary Purpose
Surgical Approach & Incisions
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
condylectomy
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Approach & Incisions focused on measuring condylectomy, TMJ function, intraoral approach
Eligibility Criteria
Inclusion Criteria:
- Patients with mandible condylar hyperplasia or osteoma who need to do the condylectomy to prevent the active growth of the affected mandible condyle and the consequence progressive facial asymmetry
- Usually the patients have TMJ functional disorder; and the SPECT shows difference greater than 20% (pixel count) between the affected side and the contralateral normal side.
Exclusion Criteria:
- Patients with contradictions to do the operation procedure and general anesthesia, patients refuse to accept the condylectomy, or patients can't afford the extra cost for the application of digital techniques are excluded from this study
Sites / Locations
- Peking University Hospital of StomatologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intraoral condylectomy via coronoid process resction
Arm Description
This procedure has no facial nerve injury and skin scar,little injury to TMJ anatomy and function.
Outcomes
Primary Outcome Measures
complications of condylectomy
to record the complications of the operation and the TMJ function recovering.
Secondary Outcome Measures
Full Information
NCT ID
NCT02120495
First Posted
April 18, 2014
Last Updated
November 19, 2014
Sponsor
Peking University
Collaborators
Beijing Municipal Science & Technology Commission
1. Study Identification
Unique Protocol Identification Number
NCT02120495
Brief Title
Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
Official Title
Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Beijing Municipal Science & Technology Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will apply the digital techniques to do the condylectomy through an intraoral approach without needing to do the intraoral vertical ramus osteotomy (IVRO). This new surgical technique will greatly maintain the TMJ anatomy structure, reduce the risk and increase the precision of the operation procedure.
Detailed Description
In this study we will use the digital techniques such as pre-surgical visual treatment planning, real time surgical navigation system, endoscope techniques, to do the intraoral condylectomy via coronoid process resection. After the condyle lesion resection, the coronoid process will be reimplanted and fixed by stainless steel wire. By using these techniques we can safely and precisely cut proper size and position of the condyle lesion as we pre-surgically designed, and at the same time greatly maintain the temporomandibular joint anatomy structure. Since we don't need to do the mandible vertical ramus osteotomy, and no conventional extraoral incision will be needed, the surgical injury will be minimized and the TMJ function will recover soon postoperatively. Additionally, the intraoral approach can avoid the risk of facial nerve injury, salivary fistula and skin scar, so it has better aesthetic results than the preauricular approach and the submandibular approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Approach & Incisions
Keywords
condylectomy, TMJ function, intraoral approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intraoral condylectomy via coronoid process resction
Arm Type
Experimental
Arm Description
This procedure has no facial nerve injury and skin scar,little injury to TMJ anatomy and function.
Intervention Type
Procedure
Intervention Name(s)
condylectomy
Other Intervention Name(s)
surgical approach
Intervention Description
The condylectomy via intraoral approach will avoid the risk of facial nerve injury and skin scar compared with the preauricular incision.And it can also greatly reserve the temporomandibular jiont anatomy and function.
Primary Outcome Measure Information:
Title
complications of condylectomy
Description
to record the complications of the operation and the TMJ function recovering.
Time Frame
post-operative day 7 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with mandible condylar hyperplasia or osteoma who need to do the condylectomy to prevent the active growth of the affected mandible condyle and the consequence progressive facial asymmetry
Usually the patients have TMJ functional disorder; and the SPECT shows difference greater than 20% (pixel count) between the affected side and the contralateral normal side.
Exclusion Criteria:
Patients with contradictions to do the operation procedure and general anesthesia, patients refuse to accept the condylectomy, or patients can't afford the extra cost for the application of digital techniques are excluded from this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaoxia wang
Phone
86-10-82195695
Email
doctorwang66@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaoxia wang, MD
Organizational Affiliation
Peking University School of Stomatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Hospital of Stomatology
City
South Zhongguancun Avenue22
State/Province
Beijing
ZIP/Postal Code
100081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaoxia wang
Phone
86-10-82195695
Email
doctorwang66@sina.com
First Name & Middle Initial & Last Name & Degree
xiaoxia wang
12. IPD Sharing Statement
Learn more about this trial
Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
We'll reach out to this number within 24 hrs