Therapeutics of Bilateral Maxillofacial InjuriesNCT01875887
Treatment of Bilateral Maxillofacial Post-traumatic Deformities
An observational study of Therapeutics of Bilateral Maxillofacial Injuries, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 53 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Therapeutics of Bilateral Maxillofacial Injuries
- What is being tested?
- rapid prototyping technology
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Apr 2013
- Phase
- Observational
- 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 18 to 53 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: patients with Bilateral maxillofacial Post-traumatic Deformities
Who may be able to join
- Bilateral maxillofacial Post-traumatic Deformities
Who cannot join
- unilateral maxillofacialPost-traumatic Deformities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- rapid prototyping technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid prototyping technologyProcedure or surgery
Rapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities
| Study group | Role | What they receive |
|---|---|---|
| treat bilateral maxillofacial deformties | treatment of bilateral maxillofacial post-traumatic deformities Receives: Procedure: rapid prototyping technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in mouth openning
The follow-ups showed that the degree of mouth opening of all patients were over 30mm.
Measured: from 1 month to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMay 2008
- Primary completionApr 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutics of Bilateral Maxillofacial InjuriesStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junhui Cui, West China Hospital
- Investigators
- Lei Liu, DMD, Study director, Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875887
- Sponsor's protocol ID
- cui_owen
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Surgery Planning Software, Rapid Prototyping Model and Preshaped Titanium Plates in Treatment of Bilateral Maxillofacial Post-traumatic Deformities
- ClinicalTrials.gov ID
- NCT01875887
- Acronym / sponsor ID
- cui_owen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jun 2013 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treat bilateral maxillofacial deformties | – | Procedure: rapid prototyping technologytreatment of bilateral maxillofacial post-traumatic deformities |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with Bilateral maxillofacial Post-traumatic Deformities
Key inclusion criteria (1 listed)
- Bilateral maxillofacial Post-traumatic Deformities
Key exclusion criteria (1 listed)
- unilateral maxillofacialPost-traumatic Deformities
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 |
|---|---|---|
| rapid prototyping technologyRapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities | Procedure or surgery | treat bilateral maxillofacial deformties |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- The West China Hospital of Stomatology has long been ranked as one of the national top hospitals in ChinaLink provided by the sponsor.
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.
Lei Liu, DMD study director
Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutics of Bilateral Maxillofacial Injuries, run by West China Hospital 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 1 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: finished, as of the sponsor's last update on 12 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in mouth openning (time frame: from 1 month to 1year). 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 12 Jun 2013.