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

Facial Asymmetry Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03845088
• Other study ID #: schen
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Peking University
• Contact: Shuo Chen, MD
• Phone: +86 15910920699
• Email: chenshuo-88[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosis
• Congenital Abnormalities
• Facial Asymmetry
• Jaw Abnormalities
• Temporomandibular Joint Ankylosis

Intervention

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

Locations

Country	Name	City	State
China	Peking University Hospital of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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