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CTRI Number  CTRI/2020/10/028475 [Registered on: 20/10/2020] Trial Registered Retrospectively
Last Modified On: 17/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Cluster Randomized Trial 
Public Title of Study   jaw growth after joint fusion treatment  
Scientific Title of Study   Cluster randomized controlled superiority trial to evaluate the growth outcomes and jaw functions after interposition arthroplasty with costochondral graft versus gap arthroplasty in the management of temporomandibular ankylosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajoy Roychoudhury 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Oral and Maxillofacial Surgery CDER AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126589303  
Fax  911126588641  
Email  ajoyroy@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ajoy Roychoudhury 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Oral and Maxillofacial Surgery CDER AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126589303  
Fax  911126588641  
Email  ajoyroy@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajoy Roychoudhury 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences New Delhi 
Address  Department of Oral and Maxillofacial Surgery CDER AIIMS New Delhi

South
DELHI
110029
India 
Phone  01126589303  
Fax  911126588641  
Email  ajoyroy@hotmail.com  
 
Source of Monetary or Material Support  
ICMR Ansari Nagar New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajoy Roychoudhury  All India Institute of Medical Sciences  Department of Oral & Maxillofacial Surgery Room No 111 CDER AIIMS New Delhi
South
DELHI 
01126589303
01126588641
ajoyroy@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Temporomandibular joint ankylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention Group A: Costochondral graft (CCG) interposition arthroplasty  35 joints will receive CCG intervention after release of ankylosis and will be followed for growth  
Comparator Agent  Intervention Group B: Gap arthroplasty  35 joints will be operated for ankylosis with gap arthroplasty and will be followed for growth changes 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  patients with unilateral or bilateral temporomandibular joint ankylosis 
 
ExclusionCriteria 
Details  1. Recurrent ankylosis
2. Ankylosis due to systemic conditions like rheumatoid arthritis
3. Age >12 years
4. Patients with obstructive sleep apnea syndrome
5. Patients refusing consent for follow up
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
growth in joints with costochondral graft interposition arthroplasty for significant superiority over adequate growth in joints with gap arthroplasty treatment  Primary outcome will be assessed by radiographs taken at different follow-up (immediately postoperative, at 1 month, 6 month, 12-months and yearly thereafter). Panoramic radiograph will be taken to observe for heterotopic bone formation.  
 
Secondary Outcome  
Outcome  TimePoints 
functional outcomes of gap arthroplasty in the management of temporomandibular ankylosis.
evaluate the functional outcomes of interposition arthroplasty with costochondral graft in the management of temporomandibular ankylosis.
compare the functional outcomes of both the treatment modalities in the management of temporomandibular ankylosis. 
6,12,18,24 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Functional outcomes of gap and interposition arthroplasty in the treatment of temporomandibular joint ankylosis. Journal of Oral and Maxillofacial Surgery J Oral Maxillofac Surg accepted 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Temporomandibular joint (TMJ) ankylosis is a problem peculiar to India and Indian subcontinent. The patient develops many subsequent problems like nutritional deficit, aesthetic deformity due to interruption of growth and obstructive sleep apnea syndrome.

The treatment is release of ankylosis with creation of Gap or interposition of various autogenous or alloplastic materials. The loss of condylar cartilage, which is thought to be a growth center, is said to cause the cessation of mandibular growth in subsequent growing period in children who are operated in growing period. This results in asymmetry, retrognathia and sometimes problems of obstructive sleep apnea.

There are conflicting views whether the condyle is primary growth center or is the matrix of muscle around mandible, which again becomes functional after release induces growth. The functional matrix theory is well known. This confusion has led to growth center transplantation in the released condyle by either costochondral joint ( CCG) or sternoclavicular joint.

The aim of the study is to scientifically document the growth of mandible after release of TMJ ankylosis. The Gap arthroplasty proponents believe that the growth of mandible after release of ankylosis can catch up as a result of muscle matrix being functional again and the growth center transplantation school bases its assumptions on the condylar growth center theory.

There has never been any study on actual quantification of growth after Gap or costochondral (CCG) interposition arthroplasty. The growth reporting has largely been based on personal observations from case reports/ series. There have been conflicting reports in the literature about both and none have shown predictable growth.

The proposed research work will test the CCG arthroplasty and gap arthroplasty in a superiority trial and will help obtaining level-I evidence for growth center transplantation requirements in TMJ ankylosis. This will also establish which procedure has less recurrence associated with it.

 
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