| CTRI Number |
CTRI/2024/02/062631 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessing effect of Platelet Rich Plasma on Pain levels and mouth opening in patients with mandibular condylar fractures |
|
Scientific Title of Study
|
Evaluating the efficacy of intra-articular Platelet Rich Plasma (PRP) injection on pain, function and post traumatic temporomandibular joint dysfunction in patients with unilateral condylar fracture of mandible. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 24/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Revati Kale |
| Designation |
PG Student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Bannimantap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
|
| Fax |
|
| Email |
revati1507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujeeth Kumar Shetty |
| Designation |
Professor and Head |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, Bannimantap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9741517281 |
| Fax |
|
| Email |
shettymaxfax@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Revati Kale |
| Designation |
PG Student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital, bannimantap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
8149411997 |
| Fax |
|
| Email |
revati1507@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Academy of Higher Education and Research, Mysore |
|
|
Primary Sponsor
|
| Name |
JSS Academy of Higher Education and Research |
| Address |
Sri Shivarathreeshwara nagara, Mysore-570015 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Revati Kale |
JSS Dental College and Hospital |
Department of Oral and Maxillofacial Surgery, JSS Dental College and Hospital Bangalore - Mysore Rd, Sri, Shivarathreeshwara Nagar, Bannimantap, Mysuru
Mysore
KARNATAKA |
8149411997
revati1507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Dental College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intermaxillary fixation |
Patients is control group will be put on 3 weeks of intermaxillary fixation, which is the standard protocol for non surgical management of condylar fractures of mandible |
| Intervention |
Platelet Rich Plasma |
injection of Platelet Rich Plasma in Temporomandibular joint followed by placement of intermaxillary fixation for 3 weeks for patients with unilateral condylar fractures of mandible |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Unilateral condylar head and high neck condylar fractures of mandible (based on AO classification) 2)Adults above the age of 18yrs and up to 60 years of age.
3) Patients consenting for the study
|
|
| ExclusionCriteria |
| Details |
1)Low condylar neck or sub condylar fractures (According to AO classification)
3)Patients below the age of 18 yrs and above the age of 60 years.
4)Patients with pre-existing Temporomandibular Joint disorders.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1) maximum mouth opening ( Measured by inter-incisal distance)
2) Pain score from 0-10 ("0" being no pain and "10" being worst possible pain)
3) The need for a second round of intermaxillary fixation was recorded ( As Yes or no)
|
1) Baseline
2) 4 weeks
3) 6 weeks
4) 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of post traumatic Temporomandibular joint disorders(As yes or no) |
3 month follow up-Incidence of post traumatic Temporomandibular joint disorders |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Condylar fractures are a commonly encountered problem in oral and maxillofacial surgery, and its treatment has always been a topic of debate. Research is always ongoing to reach a consensus for a set treatment protocol for providing optimum functional outcome. In the interest of bettering patient outcomes in condylar fractures, this study aims to evaluate the efficacy of intra articular injection of Platelet Rich Plasma in improving pain, function, need for secondary treatment and post traumatic Temporomandibular Joint dysfunctions in patients with unilateral condylar fractures of mandible. |