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NCT01875887 Clinical Trial

Treatment of Bilateral Maxillofacial Post-traumatic Deformities

Therapeutics of Bilateral Maxillofacial Injuries Clinical Trial

Official title:
Application of Surgery Planning Software, Rapid Prototyping Model and Preshaped Titanium Plates in Treatment of Bilateral Maxillofacial Post-traumatic Deformities

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01875887
Other study ID # cui_owen
Secondary ID
Status Completed
Phase N/A
First received June 4, 2013
Last updated June 7, 2013
Start date May 2008
Est. completion date April 2013

Study information
Verified date June 2013
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date April 2013
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 53 Years
Eligibility Inclusion Criteria:

- Bilateral maxillofacial Post-traumatic Deformities

Exclusion Criteria:

- unilateral maxillofacialPost-traumatic Deformities

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• rapid prototyping technology
Rapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities

Locations
Country Name City State
China West China Hospital of Stomatology Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary improvement in mouth openning The follow-ups showed that the degree of mouth opening of all patients were over 30mm. from 1 month to 1year Yes

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