| CTRI Number |
CTRI/2024/06/068444 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
oral collagen supplement and i-ipf in patient with temporomandibular joint disorder along with arthrocentesis procedure |
|
Scientific Title of Study
|
Efficacy of Oral nutraceutical as adjunct to arthrocentesis -
iPRF in Temporomandibular joint derangements - A Randomized
Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Chugh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences AIIMS - Jodhpur |
| Address |
DEPT. OF DENTISTRY , All India Institute of Medical Sciences , Jodhpur , Rajasthan 342005
All India Institute of Medical Sciences , Jodhpur , Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996891 |
| Fax |
|
| Email |
ankitamody@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Chugh |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences AIIMS - Jodhpur |
| Address |
DEPT. OF DENTISTRY ,All India Institute of Medical Sciences , Jodhpur , Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996891 |
| Fax |
|
| Email |
ankitamody@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhav Alone |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DEPT. OF DENTISTRY |
| Address |
DEPT. OF DENTISTRY ,All India Institute of Medical Sciences , Jodhpur , Rajasthan 342005
AT TAKLI DARNE , POST. GIROLI, TALUKA DEOLI, DIST WARDHA , STATE MAHARASHTRA
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09834418201 |
| Fax |
|
| Email |
vaibhavalone912@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPT. OF DENTISTRY ,All India Institute of Medical Sciences , Jodhpur , Rajasthan 342005 |
|
|
Primary Sponsor
|
| Name |
Vaibhav Alone |
| Address |
All India Institute of Medical Sciences , Jodhpur , Rajasthan 342005 |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrAnkita chugh |
all India institute of medical sciences, jodhpur |
All India institute of medical sciences, jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN |
8003996891
ankitamody@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS,Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral nutraceutical supplement |
( collagen + sodium hyaluronate + curcumin + Boswellia + Piperine ) |
| Comparator Agent |
PLACEBO GROUP |
PLACEBO GROUP ( TAB PLACEBO BD x 2 months ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who have given written informed consent to be a part of the study.
2. Adult patients of either sex Age 18-60 years
3. ASA I or ll
4.Patients with Wilkes classification of Internal Derangement stage III and stage IV only with positive Mahan
test |
|
| ExclusionCriteria |
| Details |
1. Age <18 years and >60 years
2. Pregnant or lactating female
3. Patients with severe debilitating conditions such as uncontrolled diabetes mellitus, uncontrolled hypertension,
cardio respiratory conditions, previous history of cerebrovascular accidents, myocardial infarction, coronary
artery disease, impaired renal and hepatic function and coagulation disorders
4.Patients on antiplatelet/anticoagulant therapy.
5.autoimmune diseases affecting joints
6.Significant mechanical obstruction that prevents mouth opening,
7.Acute capsulitis , synovitis
8.Benign or malignant temporomandibular joint lesions,
9.Neurological disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the analgesic efficacy oral nutraceutical (Collagen + sodium hyaluronate +
Curcurmin + Boswellia + piperine) as adjunct to arthrocentesis- iPRF in management of patients with
Temporomandibular joint derangement . |
DAY 0
7 DAY
14 DAY
1 MONTH
3 MONTHS
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate & compare the effect on jaw function (mouth opening, lateral movement, protrusive
movements) of Temporomandibular joint derangement patients in oral nutraceutical ( collagen +
sodium hyaluronate + curcumin + Boswellia + Piperine ) along with arthrocentesis and- iPRF versus
arthrocentesis - iPRF alone .
2. To evaluate & compare the radiologic changes (MRI) in patients of Temporomandibular joint
derangement treated with oral nutraceutical supplement ( collagen + sodium hyaluronate + curcumin
+ Boswellia + Piperine ) along with arthrocentesis & I-PRF versus arthrocentesis & I-PRF alone.
3. To evaluate & compare the quality of life in Temporomandibular joint derangement patients treated
with oral nutraceutical supplement ( collagen + sodium hyaluronate + curcumin + Boswellia +
Piperine ) along with arthrocentesis & iPRF versus arthrocentesis & iPRF alone . |
DAY 0
7 DAY
14 DAY
1 MONTH
3 MONTHS
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this randomized control study, we will be comparing the the to compare the efficacy of oral nutraceutical (Collagen + sodium hyaluronate + Curcumin + Boswellia + Piperine) as adjunct to arthrocentesis - iPRF in management of patients with Temporomandibular joint derangement patients.Patient will be recruited from Dentak OPD of the AIIMS , JODHPUR. A total of 30 patients will be randomly divided into 2 group those who are diagnosed with Wilkes’s type III and IV TMD by means of clinical and radiographic magnetic resonance imaging (MRI)) evaluation. Group l – Arthrocentesis + I PRF group (control group) Group ll – (Treatment group) - Arthrocentesis + I PRF + oral nutraceutical supplement(Tab Cartilox Go) in OD dose for 2 months.MMO will be measured as the distance between the incisal edge of the upper and lower central incisors using a vernier calliper. MMO measurements will be performed preoperatively ,immediately after the procedure , and at 1 week, 1 month, 3 months and 6 months postoperatively. Lateral movements are measured by instructing the patient to move his/her mandible as far as possible to one side, and the lateral movements are recorded. For convenience the distance between the fixed maxillary midline and the shift of the mandibular midline on lateral excursion is measured. Any lateral movement less than 8 mm suggests restricted movement at 1 week, 1 month, 3 months and 6 months postoperatively. The protrusive movement can be obtained by instructing the patient to close in centric position and slide the lower jaw as far forward as possible. The overjet may also be recorded. Protrusive movements are recorded by adding these two readings. Protrusive movements are considered to be restricted if it is less than 7 mm at 1 week, 1 month, 3 months and 6 months postoperatively. Placing two fingers over each condyle the patient is instructed to make a maximal jaw opening. During this movement, clicking sounds should be noted at1 week, 1 month, 3 months and 6 months postoperatively.All joints will be scanned with the patient’s mouth closed in maximum intercuspation and opened maximally, before procedure and at3 rd , and 6 th months after the procedure. The MRI studies will be independently examined by 1 of the investigators, who are blinded to the patients’ names and clinical information. Differences in preoperative and postoperative disk position, mobility, morphology, Joint effusion, Bone marrow edema and Osteoarthrosis on MRI. |