Surgical Approach & IncisionsNCT02120495
Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
A study testing condylectomy in people with Surgical Approach & Incisions, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Surgical Approach & Incisions
- What is being tested?
- condylectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Hospital of Stomatology
South Zhongguancun Avenue22, Beijing Municipality, 100081
xiaoxia wang, 86-10-82195695, doctorwang66@sina.com
xiaoxia wang
About this study
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.
Read the 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.
- Conditions
- Surgical Approach & Incisions
- Being tested
- condylectomy
- Keywords
- condylectomy, TMJ function, intraoral approach
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
condylectomyProcedure or surgery
Also called surgical approach
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.
| Study group | Role | What they receive |
|---|---|---|
| intraoral condylectomy via coronoid process resction | Experimental | This procedure has no facial nerve injury and skin scar,little injury to TMJ anatomy and function. Receives: Procedure: condylectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications of condylectomy
to record the complications of the operation and the TMJ function recovering.
Measured: post-operative day 7 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Approach & IncisionsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, wang xiaoxia, Peking University
- Investigators
- xiaoxia wang, MD, Principal investigator, Peking University School of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120495
- Sponsor's protocol ID
- wxiaoxia1
- Status last verified
- Nov 2014
- First submitted
- 18 Apr 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
- ClinicalTrials.gov ID
- NCT02120495
- Acronym / sponsor ID
- wxiaoxia1
- Conditions
- Surgical Approach & Incisions
- Keywords
- condylectomy, TMJ function, intraoral approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- May 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraoral condylectomy via coronoid process resction | Experimental | Procedure: condylectomyThis procedure has no facial nerve injury and skin scar,little injury to TMJ anatomy and function. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| condylectomyAlso: surgical approachThe 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. | Procedure or surgery | intraoral condylectomy via coronoid process resction |
Primary outcome
complications of condylectomy
Time frame: post-operative day 7 and 6 months
to record the complications of the operation and the TMJ function recovering.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaoxia wang, MD principal investigator
Peking University School of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing condylectomy in people with Surgical Approach & Incisions, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaoxia wang (86-10-82195695, doctorwang66@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications of condylectomy (time frame: post-operative day 7 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.