| CTRI Number |
CTRI/2019/09/021118 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
09/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intraoral vertical ramus osteotomy vs High condylectomy and disc repositioning |
|
Scientific Title of Study
|
Comparison of Intraoral vertical ramus osteotomy and High condylectomy with disc repositioning in the management of non-reducing disc displacement of TMJ – A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arunkumar Shadamarshan R |
| Designation |
Dental Officer (Oral And Maxillofacial Surgery) |
| Affiliation |
Army Dental Corps, Indian Army |
| Address |
Vajra Corps Dental Unit
Opposite Military Hospital
Jalandhar Cantt
144005
Jalandhar
PUNJAB
144005
India |
| Phone |
|
| Fax |
|
| Email |
shadamarshan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Arunkumar Shadamarshan R |
| Designation |
Dental Officer (Oral And Maxillofacial Surgery) |
| Affiliation |
Army Dental Corps, Indian Army |
| Address |
Vajra Corps Dental Unit
Opposite Military Hospital
Jalandhar Cantt
144005
Jalandhar
PUNJAB
144005
India |
| Phone |
|
| Fax |
|
| Email |
shadamarshan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Arunkumar Shadamarshan R |
| Designation |
Dental Officer (Oral And Maxillofacial Surgery) |
| Affiliation |
Army Dental Corps, Indian Army |
| Address |
Vajra Corps Dental Unit
Opposite Military Hospital
Jalandhar Cantt
144005
Jalandhar
PUNJAB
144005
India |
| Phone |
|
| Fax |
|
| Email |
shadamarshan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Office of the DGAFMS/DG-3B,
Raksha Mantralaya Karyalaya Maha Nideshak
Sashastra Sena Chikitsa Sewa
M Block, New Delhi – 110001 |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical Research Committee |
| Address |
DG-3B
Office of the Dir Gen Armed Forces Medical Services,
Ministry of Defence, Pin - 908713
C/o 56 APO |
| 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 |
| Maj Arunkumar Shadamarshan R |
11 Corps Dental Unit |
Surgery No.4,
Vajra Corps Dental Unit,
Opposite Military Hospital,
Jalandhar Cantt
Jalandhar
PUNJAB |
9604467659
shadamarshan@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 11 Corps Dental Unit ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High Condylectomy with disc repositioning |
Disc repositioning with high condylectomy is an open joint procedure that increases the joint space and repositions the disc to improve the condyle-disc relationship |
| Intervention |
Intraoral Vertical Ramus osteotomy |
Intraoral vertical ramus osteotomy is a non-articular surgical procedure that increases the joint space and decreases the joint loading that may lead to resolution of non-reducing disc displacement of the TMJ |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical diagnosis of Non-reducing disc displacement
2. MRI evidence of Non-reducing disc displacement
3. Unsuccessful non-surgical treatment for atleast 06 months
4. Willing for a follow up of 02 years
|
|
| ExclusionCriteria |
| Details |
1. Previous H/o TMJ surgery or orthognathic surgery
2. Dentofacial deformities
3. Other TMJ arthritides/ pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Parameters
1 Pain
2 Mandibular function impairment questionnaire
3 Maximal Interincisal opening
4 Maximal Protrusion
5 Maximal Laterotrusion to affected side
6 Maximal Laterotrusion to unaffected side
7 Deviation on mouth opening
8 Clicking of the affected joint
9 Crepitus of the affected joint
10 Occlusal disturbances
11 Tenderness of TMJ
12 Tenderness of muscles of mastication |
0, 3, 6, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiological Parameters:
13. Position of interarticular disc at closed mouth position
14. Position of interarticular disc at open mouth position
15. Joint effusion
16. Anatomy of interarticular disc
17. Bony changes in the superior articular surface
18. Bony changes in the inferior articular surface
|
0 and 12 months |
Post-operative Morbidity Parameters:
19. Temporary Facial Nerve Paresis
20. Permanent Facial Nerve Palsy
21. Facial Scar
22. Unfavorable bony split
23. Weight Loss
24. Subjective overall assessment of procedure
|
Pre op and 12 months |
Resource Parameters with special reference to the Armed Forces:
25. Time taken for unrestricted function
26. No. of additional post-operative sittings
27. Sickness absentism (in days)
28. Medical category
|
12 months post op |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/04/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
30 subjects
fulfilling the inclusion and exclusion criteria will be randomly allocated into
02 groups after informed consent. Pre-operative MRI and clinical parameters
will be recorded for all patients. The patients will be randomly allocated to
02 groups. Group A will be managed by Intraoral Vertical ramus osteotomy
followed by Maxillomandibular fixation for 02 weeks and Group B will be managed
by high condylectomy with disc repositioning by partial/full thickness excision
with/without lateral tuberclectomy according to existing contemporary surgical
protocols. The clinical parameters will be recorded at 03, 06 and 12 months post-operatively. Post-operative MRI will be
taken at 12 months post-surgery and assessed. The results will be analysed
using appropriate statistical tests to establish the efficacy of both the
procedures and to establish a comparison between the two procedures |