- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875887
Treatment of Bilateral Maxillofacial Post-traumatic Deformities
June 7, 2013 updated by: Junhui Cui, West China Hospital
Application of Surgery Planning Software, Rapid Prototyping Model and Preshaped Titanium Plates in Treatment of Bilateral Maxillofacial Post-traumatic Deformities
Combined application of surgery planning software and rapid prototyping technology and preshaped titanium plates can effectively promote the accuracy of the diagnosis and treatment of bilateral maxillofacial post traumatic deformities, reduce operation time and improve surgical effect.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
All patients underwent preoperative CT scan.
Firstly, SurgiCase were used to analyze CT data and design preliminary surgery plans.
Secondly, three-dimensions resin skull models were produced by rapid prototyping technology.
Model surgeries were performed to determine the location, reduction direction and shift distance of osteotomy.
Based on the surgical simulation, the preliminary surgery plans were validated and optimized.
Then, the titanium plates and mesh were preshaped on the models.
Finally, according to the final surgery plans the operations were performed.
The operation time, therapeutic effects and complications were observed.
The follow-up periods were 1-12 months.
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital of Stomatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 53 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
patients with Bilateral maxillofacial Post-traumatic Deformities
Description
Inclusion Criteria:
- Bilateral maxillofacial Post-traumatic Deformities
Exclusion Criteria:
- unilateral maxillofacialPost-traumatic Deformities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
treat bilateral maxillofacial deformties
treatment of bilateral maxillofacial post-traumatic deformities
|
Rapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improvement in mouth openning
Time Frame: from 1 month to 1year
|
The follow-ups showed that the degree of mouth opening of all patients were over 30mm.
|
from 1 month to 1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lei Liu, DMD, Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 4, 2013
First Submitted That Met QC Criteria
June 7, 2013
First Posted (Estimate)
June 12, 2013
Study Record Updates
Last Update Posted (Estimate)
June 12, 2013
Last Update Submitted That Met QC Criteria
June 7, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cui_owen
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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