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
|
|
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
|
|
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.
|