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Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity

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ClinicalTrials.gov Identifier: NCT03845088
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
shuo chen, Peking University

Brief 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.

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.


Condition or disease Intervention/treatment
Temporomandibular Joint Ankylosis Facial Asymmetry Procedure: temporomandibular jont reconstruction with costochondral transplantation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity.
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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;

Procedure: temporomandibular jont reconstruction with costochondral transplantation
temporomandibular jont reconstruction with costochondral transplantation guided by virtual mandibular position




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients are surgically treated in the Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.
Criteria

Inclusion Criteria:

-<12 years old

  • Unilateral temporomandibular joint ankylosis or condyle absence;
  • Temporomandibular joint reconstructed with costochondral graft;

Exclusion Criteria:

  • Bilateral temporomandibular joint ankylosis or condyle absence
  • Combined with systematic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845088


Contacts
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Contact: Shuo Chen, MD +86 15910920699 chenshuo-88@163.com

Locations
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China, Beijing
Peking University Hospital of Stomatology Recruiting
Beijing, Beijing, China, 100081
Contact: Shuo Chen, MD         
Sponsors and Collaborators
Peking University
Investigators
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Study Chair: Yi Zhang, PhD Peking University Hospital of Stomatology

Additional Information:

Publications:
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Responsible Party: shuo chen, Attending Doctor, Peking University
ClinicalTrials.gov Identifier: NCT03845088     History of Changes
Other Study ID Numbers: schen
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data was published 6 months at the end of the trial, through the form of paper publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by shuo chen, Peking University:
Virtual mandibular position; temporomandibular joint reconstruction; Jaw deformity;Costochondral graft
Additional relevant MeSH terms:
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Ankylosis
Jaw Abnormalities
Congenital Abnormalities
Facial Asymmetry
Joint Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Jaw Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities