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

NCT03845088 — Unknown, 15 participants, Peking University

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

Registry	NCT03845088
Status	Unknown
Study type	Observational
Enrollment	15 (Estimated)
Sponsor	Peking University (Other)
Conditions	Temporomandibular Joint Ankylosis, Facial Asymmetry
Interventions	temporomandibular jont reconstruction with costochondral transplantation (Procedure)
Dates	start 2018-09-01, primary completion 2024-09-01 (estimated), completion 2024-12-31 (estimated), first posted 2019-02-19, last updated 2023-04-10
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Children TMJA or condyle absence with Jaw Deformity		Procedure: temporomandibular jont reconstruction with costochondral transplantation	inclusion criteria: <12 years old; Unilateral temporomandibular joint ankylosis or condyle absence； Temporomandibular joint reconstructed with costochondral graft；

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

+Outcome measures

Primary outcomes

Bilateral ramus height,chin deviation,maxilla height [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 [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. [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）

+Eligibility

Sex: All, ages: 6 Years to 12 Years

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

+Locations (1)

Facility	City	Country	Status
Peking University Hospital of Stomatology	Beijing, Beijing Municipality	China	Recruiting

+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. PMID 21772189
Kaban 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. PMID 2213309
Kaban 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. PMID 19686936
Perrott 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. PMID 7699266
Padwa 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. PMID 9461132
Zhu 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. PMID 22117712
Lu 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. PMID 24613028

+Investigators

Yi Zhang, PhD, Study chair, Peking University Hospital of Stomatology