| CTRI Number |
CTRI/2020/11/029024 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
ASSESSMENT OF A NEW SURGICAL TECHNIQUE FOR FUSION OF LOWER JAW JOINT AND INVESTIGATING THE NATURE OF THE DISEASE |
|
Scientific Title of Study
|
ASSESSMENT OF A MORPHOFUNCTIONAL APPROACH TO TEMPOROMANDIBULAR JOINT ANKYLOSIS AND A PROTEOMIC AND GENOMIC STUDY OF THE DISEASE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YEC-1/2020/020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha Upadya |
| Designation |
Reader |
| Affiliation |
Yenepoya Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
Yenepoya Dental College and Hospital
Deralakatte
Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09740536292 |
| Fax |
|
| Email |
varsha.upadya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varsha Upadya |
| Designation |
Reader |
| Affiliation |
Yenepoya Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
Yenepoya Dental College and hospital
Deralakatte
Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09740536292 |
| Fax |
|
| Email |
varsha.upadya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Upadya |
| Designation |
Reader |
| Affiliation |
Yenepoya Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery
Yenepoya Dental College and Hospital
Deralakatte
Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09740536292 |
| Fax |
|
| Email |
varsha.upadya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Yenepoya University |
| Address |
Department of Oral and Maxillofacial Surgery
Yenepoya Dental College
Deralakatte
Mangalore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srinivas Gosla Reddy |
GSR Institute of Craniomaxillofacial Surgery |
GSR Institute of Craniomaxillofacial Surgery
#17-1-383/55,
Vinaynagar Colony, Saidabad,
Hyderabad 500059
Telangana, India.
Hyderabad
TELANGANA |
9849016969
goslareddy@gmail.com |
| Varsha Upadya |
Yenepoya Dental College |
Department of Oral and Maxillofacial Surgery, Yenepoya Dental College, Yenepoya Deemed to be University, Mangalore- 575018
Dakshina Kannada
KARNATAKA |
09740536292
varsha.upadya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| GSR Institutional ethics committee |
Submittted/Under Review |
| Yenepoya Ethics Committe 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional interpositional arthroplasty |
Parallel osteotomy cuts are placed between the skull base and the ramus of the mandible |
| Intervention |
Morphofunctional approach |
The osteotomy cut is modified by giving a 45 degree angulation to prevent reankylosis |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients diagnosed with unilateral/bilateral, fibrous/bony ankylosis of the TMJ.
b) Patients consenting for investigations and treatment
c) AHA I, II and III patients
|
|
| ExclusionCriteria |
| Details |
a) Patients with restricted mouth opening due to causes other than ankylosis (non articular causes) such as muscle spasm, condylar fractures, oral submucous fibrosis, benign and malignant tumors.
b) Patients not fit for surgery under general anesthesia due to severe systemic illnesses (AHA IV and V)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maximum Incisal opening
Incidence of reankylosis |
Every month for the first 6 months, once in 3 months for the next one year and bi annually for the next two years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aesthetic and functional outcome |
Annual assessment post-operatively |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
18/11/2020 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim
of the study
Assessment of a Morphofunctional Approach to Temporomandibular
Joint Ankylosis and a Proteomic and Genomic Study of the Disease.
Objectives
of the study
1. Comparison of a morphofunctional approach with
conventional interpositional arthroplasty for the
management of TMJ ankylosis.
2. To identify possible genetic
markers of TMJ ankylosis by miRNA and exome sequencing
3. To identify protein expression and molecular
signaling pathways involved in TMJ ankylosis through phospho-proteomic
evaluationand compare with normal controls.
4. To propose a staging system for
TMJ ankylosis correlating the clinical, functional and radiographic features.
OBJECTIVE 1: Comparison
of a morphofunctional approach with conventional interpositional
arthroplasty for the management of TMJ ankylosis.
21 cases of conventional
interpositional arthroplasty [repository
data and prospective cases to be operated at Yenepoya (Deemed to be) University
and GSR Institue] will be
compared with a minimum of 21 cases operated
at the GSR Institute, Hyderabad, using the morphofunctional
technique i.e Osteotomy modification
+ cartilage graft for reconstruction
Maximum Incisal
Opening (MIO) will be measured pre and post- operatively and will be compared
between the groups.
Incidence of reankylosis
will be assessed and compared between the groups
OBJECTIVE 3: Genetic basis of TMJ
ankylosis
5 ml of venous blood
will be collected from 5 patients with TMJ ankylosis and 5 healthy controls as
described previously and will be subjected to miRNA and exome sequencing
OBJECTIVE 3: Phospho-proteomic analysis of the
ankylotic mass
Resected ankylotic
masses from 5 patients with TMJ ankylosis and resected normal
(non ankylosed) condyles from 5 controls will be collected and
stored as described previously and subjected to phospho-proteomic evaluation.
OBJECTIVE
4: To propose a staging system for TMJ ankylosis correlating the clinical,functional
and radiographic features.
Photographic,
radiographic and functional assessment will be carried out to propose a staging
system for TMJ ankylosis based on the severity and extent of the disease.
|