Treatment of Bilateral Maxillofacial Post-traumatic Defor... | NCT01875887

Studies
Treatment of Bilateral Maxillofacial Post-traumatic Deformities

NCT01875887

Sponsor

West China Hospital

Status

Completed

Last Update Posted

Jun 12, 2013Estimated

Enrollment

1Actual

Phase

Not provided

Conditions

Therapeutics of Bilateral Maxillofacial Injuries

Interventions

rapid prototyping technology

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 4, 2013

First Submission Date that Met QC Criteria

Jun 7, 2013

First Posted Date

Jun 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2013

Last Update Posted Date

Jun 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treat bilateral maxillofacial deformties		treatment of bilateral maxillofacial post-traumatic deformities	Procedure: rapid prototyping technology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rapid prototyping technology	Procedure	Rapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities	treat bilateral maxillofacial deformties

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bilateral maxillofacial Post-traumatic Deformities

Exclusion Criteria:

unilateral maxillofacialPost-traumatic Deformities

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

53 Years

Standard Ages

Adult

Study Population

patients with Bilateral maxillofacial Post-traumatic Deformities

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lei Liu, DMD	Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital of Stomatology		Chengdu	Sichuan	610041	China

References Module

Citations

Not provided