| CTRI Number |
CTRI/2024/12/078787 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Easing TMJ Pain Comparing Two Approaches to Treatment |
|
Scientific Title of Study
|
To evaluate the efficacy of Intra-articular injectable platelet-rich fibrin with arthrocentesis versus arthrocentesis alone in the management of temporomandibular joint internal derangement: A Prospective Study |
| 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. Sachin Jha |
| Designation |
PG Student |
| Affiliation |
Government College Of Dentistry Indore |
| Address |
Room No. 3 Department of Oral and Maxillofacial Surgery
Government College of Dentistry
1 SARDAR PATEL MARG OPPOSITE M.Y HOSPITAL
INDORE 452001
MADHYA PRADESH
India
OPP. M.Y HOSPITAL, SHIVAJI VATIKA
Indore
MADHYA PRADESH
452001
India |
| Phone |
9717744818 |
| Fax |
|
| Email |
dr.sachinjha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vilas Newaskar |
| Designation |
Professor and Head of Department |
| Affiliation |
Government College Of Dentistry Indore |
| Address |
Room No 3 Department of Oral and Maxillofacial Surgery
Government College of Dentistry
1 Sardar Patel Marg
Opposite M Y Hospital
Indore 452001
Madhya Pradesh
India
opposite M Y Hospital Shivaji Vatika
Indore
MADHYA PRADESH
452001
India |
| Phone |
9827028864 |
| Fax |
|
| Email |
vilasnewaskar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sachin Jha |
| Designation |
PG Student |
| Affiliation |
Government College Of Dentistry Indore |
| Address |
Room No 3 Department of Oral and Maxillofacial Surgery
Government College of Dentistry
1 Sardar Patel Marg
Opposite M Y Hospital
Indore 452001
Madhya Pradesh
India
Opposite M Y Hospital Shivaji Vatika
Indore
MADHYA PRADESH
452001
India |
| Phone |
9717744818 |
| Fax |
|
| Email |
dr.sachinjha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 3 Department of Oral and Maxillofacial Surgery
Government College of Dentistry
1 Sardar Patel Marg
Opposite M Y Hospital
Indore 452001
Madhya Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Government College of Dentistry Indore |
| Address |
Room No 3 Department of Oral and Maxillofacial Surgery Government College of Dentistry
1 Sardar Patel Marg
Opposite M Y Hospital
Indore 452001
Madhya Pradesh
India |
| Type of Sponsor |
Other [Government Medical College ] |
|
|
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 Sachin Jha |
Government College of Dentistry |
Room No 3 Department of Oral and Maxillofacial Surgery
Government College of Dentistry
1 Sardar Patel Marg
Opposite M Y Hospital
Indore 452001
Madhya Pradesh
India
Indore
MADHYA PRADESH |
9717744818
dr.sachinjha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government College of Dentistry |
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 |
| Intervention |
Arthrocentesis with Ringer lactate |
Dose-150-200ml Ringer Lactate
Frequency - Total 3 injection , each session single injection at 0,2,4week.
Route of administration- Intra-articular injection
Duration of intervention- 1.5-2months |
| Comparator Agent |
Arthrocentesis with Ringer lactate and injectable platelet rich fibrin |
Dose-150-200ml Ringer Lactate + 1ml i-PRF
Frequency - Total 3 injection , each session single injection at 0,2,4week.
Route of administration- Intra-articular injection
Duration of intervention- 1.5-2months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. The study included patient aged 18-55 years. suffering from TMJ internal derangement with reduction and patient who have given consent.
2. All the patients whose condition was refractory to conservative treatment were included in the study. |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from TMJ related Disorder other than Internal derangement.
2) Patients maintained on anti-coagulants, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks
was also excluded in this study.
3) Patients who were pregnant or in the lactation period.
4) Patients who were edentulous were excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of arthrocentesis with and without i-PRF injection in upper joint space on the improvement of symptoms and jaw function in management of TMJ internal derangement. |
Baseline
1 week
1 month
2 months
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare preoperative and postoperative pain in TMJ using Visual analogue scale.
2)To compare maximum mouth opening both pre and post operatively.
3)To compare clicking sound pre and postoperatively.
4)To compare the lateral Jaw Movement |
Baseline
1 week
1 month
2 months
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prospective interventional hospital-based study, with temporomandibular joint & internal derangement patients attending OPD of Oral and Maxillofacial Surgery Govt. College of Dentistry Indore Madhya Pradesh, India. Informed consent will be obtained from each patient enrolled in the study. 40 patients will be included in this study. All patients will be treated using the same method. These 40 patients will be divided into two groups of for namely group I and group 2. In group l patients, arthrocentesis will be planned and In group 2 patients, arthrocentesis with i-PRF will be planned. Preoperative inter-incisal distance will be measured using Vernier calibre |