| CTRI Number |
CTRI/2023/11/059991 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
16/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of blood product and polymer solution included blood product for the treatment of jaw joint problem. |
|
Scientific Title of Study
|
Comparison of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Combination versus Injectable Platelet-Rich Fibrin Only in Internal Derangement Of Temporomandibular Joint: A Randomized Controlled 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 |
Malya Manoj Kumar Naik |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Oral And Maxillofacial Surgery Block-3 Room No-2
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9490734248 |
| Fax |
|
| Email |
mimanojkumar21@gmaiil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U ShivajI Raju |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery Block-3 Room No-2
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9966351997 |
| Fax |
|
| Email |
shivajiraju.u@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishore Moturi |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Oral and Maxillofacial Surgery Block-3 Room No-2
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9849094159 |
| Fax |
|
| Email |
kishoremoturi@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,Vishnupur,Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Malya Manoj Kumar Naik |
| Address |
Block 3,Room No 2,Department Of Oral And Maxillofacial Surgery,
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| 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 Malya Manoj Kumar Naik |
Vishnu Dental College |
Department of Oral and Maxillofacial Surgery block-3 room no-2
Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH |
9490734248
mimanojkumar21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VISHNU DENTAL COLLEGE, BHIMAVARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injectable Platelet-Rich Fibrin |
1ml of I-PRF which is prepared from 10 ml of patient whole blood will be injected into temporomandibular joint space using needle. |
| Intervention |
Injectable Platelet-Rich Fibrin and Hyaluronic Acid Combination. |
0.5 ml of Commercially available Hyaluronic acid (Hyalgan 20gm/2ml,FIDIA) will be added to 1ml of I-PRF which is prepared from 10 ml of patient whole blood in a separate plastic test tube and thus formed 1.5 ml of homogenate solution will be injected into upper temporomandibular joint space using needle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 18-60 years.
2.Patients diagnosed with Wilkes stage II and III of ID of temporomandibular joint.
3.Patients not responding to conservative treatments.
4.Willingness to participate in the study and to give informed consent.
5.Willing for a minimum 6-month follow-up after undergoing treatment. |
|
| ExclusionCriteria |
| Details |
1.Any systemic or malignant disease that could interfere with the TMJ treatment or assessment.
2.History of Previous TMJ surgery/condylar trauma.
3.Failure during intra-articular injection procedure.
4.Fibrous or osseous ankylosis of the TMJ.
5.Cutaneous, otic, or articular infections.
6.Edentulous patients.
7.Pregnant and breastfeeding.
8.Bilateral TMJ pain.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain at rest & chewing, assessed by means of a visual analog scale.
2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements.
3.Clicking by Auscultation.
4.QOL questionnaire.
5.Functional limitation during usual jaw movements. |
1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative.
2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative.
3.Clicking at 1 Week,1 month,3 months,6 months postoperative.
4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative.
5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain at rest & chewing, assessed by means of a visual analog scale.
2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements.
3.Clicking by Auscultation.
4.QOL questionnaire.
5.Functional limitation during usual jaw movements. |
1.Pain at rest & chewing at 1 Week,1 month,3 months,6 months postoperative.
2.Mandibular range of movement, comprising maximum non assisted & assisted mouth opening, left & right laterotrusion, & protrusion movements at 1 Week,1 month,3 months,6 months postoperative.
3.Clicking at 1 Week,1 month,3 months,6 months postoperative.
4.QOL questionnaire at 1 Week,1 month,3 months,6 months postoperative.
5.Functional limitation at 1 Week,1 month,3 months,6 months postoperative. |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
30/11/2023 |
| 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) |
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
|
The aim of the study is to investigate the efficacy of combination of Hyaluronic acid, I-PRF and I-PRF alone in patients with internal derangements of the temporomandibular joint (TMJ).A total of 28 patients with tmj internal derangement will be selected from outpatient department of oral and maxillofacial surgery,vishnu dental college,bhimavaram, and will be equally divided into 2 groups of 14 each.in group-A arthrocentesis followed by i-prf injection and in group-B arthrocentesis followed by i-prf and hyaluronic acid combination.The study is interventional prospective study.computer generated randomization will be used as sampling method.The following primary outcomes a) Pain at rest and chewing b) Mandibular range of movement c) Clicking d) QOL questionnaire d)functional limitation will be measured at preoperative,1 week,1 month,3 months,6 months. The data will be analyzed individually for all the patients.There is no conflict of interest. |