Temporomandibular Joint AnkylosisNCT03845088
Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity
An observational study of Temporomandibular Joint Ankylosis and Facial Asymmetry, run by Peking University at 1 site in China.
Trial summary
Hypothesis：Computer-aided design virtual mandibular position is feasible for costochondral graft growing and occlusion stabilizing in the one-stage treatment of children temporomandibular joint ankylosis (TMJA) or condyle absence with jaw deformity. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Temporomandibular Joint Ankylosis, Facial Asymmetry
- What is being tested?
- temporomandibular jont reconstruction with costochondral transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Dec 2024
- How long will I take part?
- 10 Years
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients are surgically treated in the Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.
Who may be able to join
- <12 years old
- Unilateral temporomandibular joint ankylosis or condyle absence；
- Temporomandibular joint reconstructed with costochondral graft；
Who cannot join
- Bilateral temporomandibular joint ankylosis or condyle absence
- Combined with systematic disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Hospital of Stomatology
Beijing, Beijing Municipality, 100081
Shuo Chen, MD
About this study
Official title: Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity.
Hypothesis：Computer-aided design virtual mandibular position is feasible for costochondral graft growing and occlusion stabilizing in the one-stage treatment of children temporomandibular joint ankylosis (TMJA) or condyle absence with jaw deformity.
Methods: The inclusion criteria is children patients younger than 12 years old with unilateral TMJA or condyle absence. A virtual mandibular position is designed preoperatively according to the CT data of jaw and dentition. 3D printed templates and occlusal splints are used to guide the costochondral graft and mandibular position. During surgery, the affected ramus is reconstructed with costochondral grafting under the virtual mandibular position. After surgery, the occlusal splint is fixed to maxilla at least one month, and then, replaced by orthodontic functional appliance to promote downward growth of the maxilla. Occlusion, facial symmetry, costochondral graft growing would be evaluated and analysed until adulthood.
- Being tested
- temporomandibular jont reconstruction with costochondral transplantation
- Keywords
- Virtual mandibular position; temporomandibular joint reconstruction; Jaw deformity;Costochondral graft
- Medical subject headings
- Temporomandibular ankylosis, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporomandibular jont reconstruction with costochondral transplantationProcedure or surgery
temporomandibular jont reconstruction with costochondral transplantation guided by virtual mandibular position
| Study group | Role | What they receive |
|---|---|---|
| Children TMJA or condyle absence with Jaw Deformity | inclusion criteria: <12 years old; Unilateral temporomandibular joint ankylosis or condyle absence； Temporomandibular joint reconstructed with costochondral graft； Receives: Procedure: temporomandibular jont reconstruction with costochondral transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral ramus height,chin deviation,maxilla height
Bilateral ramus height,chin deviation,maxilla height in millimeter. These measurements were accomplished by ProPlan 2.0( SynthesProPlan，Materialise，Belgium）
Measured: preoperation
Bilateral ramus height,chin deviation,maxilla height 6 months after operation
Bilateral ramus height,chin deviation,maxilla height in millimeter 6 months after operation. These measurements were accomplished by ProPlan 2.0( SynthesProPlan，Materialise，Belgium）
Measured: 6 months after operation
Bilateral ramus height,chin deviation,maxilla height 12 months after operation.
Bilateral ramus height,chin deviation,maxilla height in millimeter 12 months after operation.These measurements were accomplished by ProPlan 2.0( SynthesProPlan，Materialise，Belgium）
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint AnkylosisStudies of the same condition, open and under way.
- More trials run by Peking 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shuo chen, Peking University
- Investigators
- Yi Zhang, PhD, Study chair, Peking University Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845088
- Sponsor's protocol ID
- schen
- Status last verified
- Apr 2023
- First submitted
- 26 Sep 2018
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was published 6 months at the end of the trial, through the form of paper publication
Publications
Zhang X, Chen M, Wu Y, Wang B, Yang C. Management of temporomandibular joint ankylosis associated with mandibular asymmetry in infancy. J Craniofac Surg. 2011 Jul;22(4):1316-9. doi: 10.1097/SCS.0b013e31821c9342.
PubMed 21772189Kaban LB, Perrott DH, Fisher K. A protocol for management of temporomandibular joint ankylosis. J Oral Maxillofac Surg. 1990 Nov;48(11):1145-51; discussion 1152. doi: 10.1016/0278-2391(90)90529-b.
PubMed 2213309Kaban LB, Bouchard C, Troulis MJ. A protocol for management of temporomandibular joint ankylosis in children. J Oral Maxillofac Surg. 2009 Sep;67(9):1966-78. doi: 10.1016/j.joms.2009.03.071.
PubMed 19686936Perrott DH, Umeda H, Kaban LB. Costochondral graft construction/reconstruction of the ramus/condyle unit: long-term follow-up. Int J Oral Maxillofac Surg. 1994 Dec;23(6 Pt 1):321-8. doi: 10.1016/s0901-5027(05)80046-3.
PubMed 7699266Padwa BL, Mulliken JB, Maghen A, Kaban LB. Midfacial growth after costochondral graft construction of the mandibular ramus in hemifacial microsomia. J Oral Maxillofac Surg. 1998 Feb;56(2):122-7; discussion 127-8. doi: 10.1016/s0278-2391(98)90847-3.
PubMed 9461132Zhu S, Li J, Luo E, Feng G, Ma Y, Hu J. Two-stage treatment protocol for management of temporomandibular joint ankylosis with secondary deformities in adults: our institution's experience. J Oral Maxillofac Surg. 2011 Dec;69(12):e565-72. doi: 10.1016/j.joms.2011.07.025.
PubMed 22117712Lu C, Huang D, He D, Yang C, Yuan J. Digital occlusal splint for condylar reconstruction in children with temporomandibular joint ankylosis. J Oral Maxillofac Surg. 2014 Aug;72(8):1585-93. doi: 10.1016/j.joms.2013.12.033. Epub 2014 Jan 15.
PubMed 24613028
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity.
- ClinicalTrials.gov ID
- NCT03845088
- Acronym / sponsor ID
- schen
- Keywords
- Virtual mandibular position; temporomandibular joint reconstruction; Jaw deformity;Costochondral graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Feb 2019 (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.
Hypothesis：Computer-aided design virtual mandibular position is feasible for costochondral graft growing and occlusion stabilizing in the one-stage treatment of children temporomandibular joint ankylosis (TMJA) or condyle absence with jaw deformity.
Methods: The inclusion criteria is children patients younger than 12 years old with unilateral TMJA or condyle absence. A virtual mandibular position is designed preoperatively according to the CT data of jaw and dentition. 3D printed templates and occlusal splints are used to guide the costochondral graft and mandibular position. During surgery, the affected ramus is reconstructed with costochondral grafting under the virtual mandibular position. After surgery, the occlusal splint is fixed to maxilla at least one month, and then, replaced by orthodontic functional appliance to promote downward growth of the maxilla. Occlusion, facial symmetry, costochondral graft growing would be evaluated and analysed until adulthood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children TMJA or condyle absence with Jaw Deformity | – | Procedure: temporomandibular jont reconstruction with costochondral transplantationinclusion criteria: <12 years old; Unilateral temporomandibular joint ankylosis or condyle absence； Temporomandibular joint reconstructed with costochondral graft； |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients are surgically treated in the Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.
Key inclusion criteria (3 listed)
- <12 years old
- Unilateral temporomandibular joint ankylosis or condyle absence；
- Temporomandibular joint reconstructed with costochondral graft；
Key exclusion criteria (2 listed)
- Bilateral temporomandibular joint ankylosis or condyle absence
- Combined with systematic disease
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 |
|---|---|---|
| temporomandibular jont reconstruction with costochondral transplantationtemporomandibular jont reconstruction with costochondral transplantation guided by virtual mandibular position | Procedure or surgery | Children TMJA or condyle absence with Jaw Deformity |
Primary outcome
Bilateral ramus height,chin deviation,maxilla height
Time frame: preoperation
Bilateral ramus height,chin deviation,maxilla height in millimeter. These measurements were accomplished by ProPlan 2.0( SynthesProPlan，Materialise，Belgium）
Bilateral ramus height,chin deviation,maxilla height 6 months after operation
Time frame: 6 months after operation
Bilateral ramus height,chin deviation,maxilla height in millimeter 6 months after operation. These measurements were accomplished by ProPlan 2.0( SynthesProPlan，Materialise，Belgium）
Bilateral ramus height,chin deviation,maxilla height 12 months after operation.
Time frame: 12 months after operation
Bilateral ramus height,chin deviation,maxilla height in millimeter 12 months after operation.These measurements were accomplished by ProPlan 2.0( SynthesProPlan，Materialise，Belgium）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Background: PubMed 21772189Zhang X, Chen M, Wu Y, Wang B, Yang C. Management of temporomandibular joint ankylosis associated with mandibular asymmetry in infancy. J Craniofac Surg. 2011 Jul;22(4):1316-9. doi: 10.1097/SCS.0b013e31821c9342.
- Background: PubMed 2213309Kaban LB, Perrott DH, Fisher K. A protocol for management of temporomandibular joint ankylosis. J Oral Maxillofac Surg. 1990 Nov;48(11):1145-51; discussion 1152. doi: 10.1016/0278-2391(90)90529-b.
- Background: PubMed 19686936Kaban LB, Bouchard C, Troulis MJ. A protocol for management of temporomandibular joint ankylosis in children. J Oral Maxillofac Surg. 2009 Sep;67(9):1966-78. doi: 10.1016/j.joms.2009.03.071.
- Background: PubMed 7699266Perrott DH, Umeda H, Kaban LB. Costochondral graft construction/reconstruction of the ramus/condyle unit: long-term follow-up. Int J Oral Maxillofac Surg. 1994 Dec;23(6 Pt 1):321-8. doi: 10.1016/s0901-5027(05)80046-3.
- Background: PubMed 9461132Padwa BL, Mulliken JB, Maghen A, Kaban LB. Midfacial growth after costochondral graft construction of the mandibular ramus in hemifacial microsomia. J Oral Maxillofac Surg. 1998 Feb;56(2):122-7; discussion 127-8. doi: 10.1016/s0278-2391(98)90847-3.
- Background: PubMed 22117712Zhu S, Li J, Luo E, Feng G, Ma Y, Hu J. Two-stage treatment protocol for management of temporomandibular joint ankylosis with secondary deformities in adults: our institution's experience. J Oral Maxillofac Surg. 2011 Dec;69(12):e565-72. doi: 10.1016/j.joms.2011.07.025.
- Background: PubMed 24613028Lu C, Huang D, He D, Yang C, Yuan J. Digital occlusal splint for condylar reconstruction in children with temporomandibular joint ankylosis. J Oral Maxillofac Surg. 2014 Aug;72(8):1585-93. doi: 10.1016/j.joms.2013.12.033. Epub 2014 Jan 15.
- Individual participant dataSharing planned: Yes. The data was published 6 months at the end of the trial, through the form of paper publication
Related trials for Temporomandibular Joint Ankylosis
RecruitingObservational study
Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Temporomandibular Joint Disorders
RecruitingObservational study
Virtual Planning of Total Temporomandibular Joint Replacement
Temporomandibular Disorders (TMD), Temporomandibular Joint Ankylosis
Not yet recruitingObservational study
Clinical, Microbial and Tissue-based Characterization of Patients Treated for Severe Temporomandibular Joint Pathology
TMJ Disorder, Ankylosis
Active, not recruiting
Patient-Specific Guides for Gap Pediatric Arthroplasty
Temporomandibular Joint Ankylosis
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.
Yi Zhang, PhD study chair
Peking University Hospital of Stomatology
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 Temporomandibular Joint Ankylosis and Facial Asymmetry, run by Peking 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 2 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 10 Apr 2023. 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 Shuo Chen, MD (+86 15910920699, chenshuo-88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral ramus height,chin deviation,maxilla height (time frame: preoperation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845088, which also lists 7 linked publications.
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 10 Apr 2023.