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

Recruiting

• Conditions: Temporomandibular Joint Ankylosis; Facial Asymmetry
• Interventions: Procedure: temporomandibular jont reconstruction with costochondral transplantation

• Registration Number: NCT03845088
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-10
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	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 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）

Trial Locations

Locations (1)

Peking University Hospital of Stomatology; 🇨🇳 Beijing, Beijing, China