MedDataX Logo

Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection

NCT ID: NCT02120495

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Approach & Incisions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intraoral condylectomy via coronoid process resction

This procedure has no facial nerve injury and skin scar,little injury to TMJ anatomy and function.

Group Type EXPERIMENTAL

condylectomy

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

condylectomy

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

surgical approach

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

wang xiaoxia

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

xiaoxia wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University School of Stomatology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Hospital of Stomatology

South Zhongguancun Avenue22, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

xiaoxia wang

Role: CONTACT

[email protected]
86-10-82195695

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

xiaoxia wang

Role: primary

[email protected]
86-10-82195695

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

wxiaoxia1

Identifier Type: -

Identifier Source: org_study_id