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

NCT03845088 | Unknown

• 1 other identifier: schen
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Ankylosis; Facial Asymmetry

Keywords

Virtual mandibular position; temporomandibular joint reconstruction; Jaw deformity;Costochondral graft

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

temporomandibular jont reconstruction with costochondral transplantation PROCEDURE

temporomandibular jont reconstruction with costochondral transplantation guided by virtual mandibular position

Children TMJA or condyle absence with Jaw Deformity

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \<12 years old
• Unilateral temporomandibular joint ankylosis or condyle absence；
• Temporomandibular joint reconstructed with costochondral graft；

You may not qualify if:

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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Temporomandibular ankylosis; Facial Asymmetry

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Zhang, PhD

  Peking University Hospital of Stomatology

  STUDY CHAIR

Central Study Contacts

Shuo Chen, MD

CONTACT

+86 15910920699; chenshuo-88@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: February 19, 2019
• Study Start: September 1, 2018
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)