Facial AsymmetryNCT03270618
Accuracy of a CAD/CAM Surgical Template for Mandible Distraction
A study testing CAD/CAM Surgical Template in people with Facial Asymmetry and Mandible; Hypoplasia, Unilateral Condylar, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Facial Asymmetry, Mandible; Hypoplasia, Unilateral Condylar, Distraction of Bone
- What is being tested?
- CAD/CAM Surgical Template
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2018
- Phase
- Interventional
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who were scheduled to undergo mandibular DO via intraoral approach
- Patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment
- Patients who agreed to participate in this study
Who cannot join
- Patients requiring more than one distractor of the mandible
- Patients with mandible defect
- Patients with previous mandibular trauma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Biao Li, Master
About this study
Official title: Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction
The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Distraction was simulated on virtual model and the new morphology of the mandible was predicted. The position and direction of the distractor was determined to achieve the optimal morphology. The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. The outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. Linear and angular differences for the distractor was measured.
- Being tested
- CAD/CAM Surgical Template
- Medical subject headings
- Facial Asymmetry, Diastasis, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM Surgical TemplateDevice
The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position.
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear differences of the distractor position
Measured: within latency period (5-7 days after the surgery)
angular differences of the distractor vector
Measured: within latency period (5-7 days after the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Jan 2014
- Primary completion30 Apr 2016
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial AsymmetryStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xudong Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Xudong Wang, Study chair, Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270618
- Sponsor's protocol ID
- cmfs02
- Status last verified
- Aug 2017
- First submitted
- 31 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction
- ClinicalTrials.gov ID
- NCT03270618
- Acronym / sponsor ID
- cmfs02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 1 Sep 2017 (actual)
- 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.
The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Distraction was simulated on virtual model and the new morphology of the mandible was predicted. The position and direction of the distractor was determined to achieve the optimal morphology. The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. The outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. Linear and angular differences for the distractor was measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who were scheduled to undergo mandibular DO via intraoral approach
- Patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment
- Patients who agreed to participate in this study
Key exclusion criteria (3 listed)
- Patients requiring more than one distractor of the mandible
- Patients with mandible defect
- Patients with previous mandibular trauma
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 |
|---|---|---|
| CAD/CAM Surgical TemplateThe templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. | Device | – |
Primary outcome
Linear differences of the distractor position
Time frame: within latency period (5-7 days after the surgery)
angular differences of the distractor vector
Time frame: within latency period (5-7 days after the surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Xudong Wang study chair
Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM Surgical Template in people with Facial Asymmetry and Mandible; Hypoplasia, Unilateral Condylar, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biao Li, Master (15900561183, benleex@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear differences of the distractor position (time frame: within latency period (5-7 days after the surgery)). The study lists 2 primary outcomes in all. 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 1 Sep 2017.