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

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.

Study Overview

• Status: Recruiting
• Conditions: Facial Asymmetry; Temporomandibular Joint Ankylosis
• Intervention / Treatment: Procedure: temporomandibular jont reconstruction with costochondral transplantation

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Shuo Chen, MD; Phone Number: +86 15910920699; Email: chenshuo-88@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100081
      • Recruiting
      • Peking University Hospital of Stomatology
      • Contact: Shuo Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）	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）	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）	12 months after operation

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Chair: Yi Zhang, PhD, Peking University Hospital of Stomatology

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Virtual mandibular position; temporomandibular joint reconstruction; Jaw deformity;Costochondral graft
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Stomatognathic System Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Facial Asymmetry; Jaw Abnormalities; Ankylosis
• Other Study ID Numbers: schen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data was published 6 months at the end of the trial, through the form of paper publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No