Clinical trial NCT03845088: Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity
Official title: Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Temporomandibular Joint Ankylosis
Facial Asymmetry
Keywords: Virtual mandibular position; temporomandibular joint reconstruction; Jaw deformity;Costochondral graft
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Bilateral ramus height,chin deviation,maxilla height
timeFrame: preoperation
measure: Bilateral ramus height,chin deviation,maxilla height 6 months after operation
timeFrame: 6 months after operation
measure: Bilateral ramus height,chin deviation,maxilla height 12 months after operation.
timeFrame: 12 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
state: Beijing
Study officials:
affiliation: Peking University Hospital of Stomatology
name: Yi Zhang, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.