| CTRI Number |
CTRI/2024/09/074037 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Automated TMJ arthrocentresis] |
| Study Design |
Other |
|
Public Title of Study
|
Automatic arthrocentesis in TMJ disorders |
|
Scientific Title of Study
|
The efficacy of automatic arthrocentesis in TMJ disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Kumar S |
| Designation |
Post graduate resident |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room No-3,Department of oral and maxillofacial surgery,sree balaji dental college and hospital,velachery main road ,narayanapuram,pallikaranai,chennai-600100
Chennai
TAMIL NADU
600100
India |
| Phone |
6379012741 |
| Fax |
|
| Email |
praveendentist3097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakash Dhanavelu |
| Designation |
professor |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room No-3,Department of oral and maxillofacial surgery,sree balaji dental college and hospital,velachery main road ,narayanapuram,pallikaranai,chennai-600100
Chennai
TAMIL NADU
600100
India |
| Phone |
9962771886 |
| Fax |
|
| Email |
prakash.oralsurgeon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash Dhanavelu |
| Designation |
Professor |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room No-3,Department of oral and maxillofacial surgery,Sree Balaji dental college and hospital,Velachery main road ,Narayanapuram,Pallikaranai,Chennai-600100
Chennai
TAMIL NADU
600100
India |
| Phone |
9962771886 |
| Fax |
|
| Email |
prakash.oralsurgeon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai 600100 |
|
|
Primary Sponsor
|
| Name |
Praveen KumarS |
| Address |
Room No-3,Department of Oral and Maxillofacial surgery,Velachery main road,Narayanapuram,Pallikaranai,Chennai-600100 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Praveen Kumar S |
Sree Balaji dental college and hospital |
Room No-3,Department of oral and maxillofacial surgery,Velachery main road,Narayanapuram,Pallikaranai,Chennai-600100
Chennai
TAMIL NADU |
6379012741
praveendentist3097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Clinical Trail) Sree Balaji dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M244||Recurrent dislocation of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Automatic TMJ irrigation |
Post operative mouth opening after 1 week 1 month and 3 months
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Pain located in affected TMJ especially during opening
Clicking sound
Restricted mouth opening less than 35 mm with TMJ pain
Difficulty in lateral movement towards the towards the unaffected side
Deviation towards the affected side in opening and protrusion movements
Patients who did not respond to conservative management including splint therapy |
|
| ExclusionCriteria |
| Details |
Patients suffering from any systemic diseases, platelets disorders, fibrinogen deficiency
Patients with previous TMJ surgery
Patients with previous joint fractures, infection
Patients receiving anticoagulation treatment or non- steroidal anti-inflammatory drugs within 48 hours preoperatively |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain relief
Mouth opening |
At baseline, 4 weeks, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clicking sound
Jaw deviations |
At baseline, 1 week, 4 week, 3 month |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
23/10/2024 |
| 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="2"
Days="6" |
|
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
|
This study aims to find the efficacy of automated arthrocentresis in TMJ disorders patient. Surgical field should be isolated and cleaned using povidone iodine, specifically the ear and pre auricular region. External auditory canal should be conserved from fluid and stagnation of blood using cotton. The auriculotemporal nerve block should be given to joint penetrating region. The arthrocentresis technique described by NITZAN et. Al. will be used. A line should be drawn from the corner of the eye to tragus and the first mark will be made 10 mm from the tragus and 0.5mm below the line. The second point will be marked 20mm from the tragus and 1mm below the line a 21 - gauge needle will be inserted into the superior joint compartment from the first point and 5ml saline solution will be injected to widen the upper joint space. A second needle, the same diameter as the first, will be inserted second point and will be manually confirmed that upper joint space was irrigated effectively. The tube of the irrigation pump will be connected to second needle and automatic irrigation was initiated |