| CTRI Number |
CTRI/2025/02/081201 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Mandibular farctures once reduced and fixed take time to heal, and bone regeneration takes time as the bone is dense. This study aims to study about rate of accelerated healing by using platelet rich plasma at the fracture site in study groups and comparing it with healing period in control groups. |
|
Scientific Title of Study
|
COMPARATIVE RADIOGRAPHIC EVALUATION OF BONE REGENERATION AT MANDIBULAR SYMPHYSIS AND PARASYMPHYSIS FRACTURE SITE WITH OR WITHOUT APPLICATION OF PLATELET RICH PLASMA (PRP). |
| 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 DIMPLE VIJAY CHAUDHARI |
| Designation |
MDS 3rd YEAR ORAL AND MAXILLOFACIAL SURGERY |
| Affiliation |
KRISHNA VISHWA VIDYAPEETH, SCHOOL OF DENTAL SCIENCES , KARAD |
| Address |
The study would be performed in DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,ROOM NO.24 SCHOOL OF DENTAL SCIENCES, KRISHNA VISHWA VIDYAPEETH,
MALKAPUR, KARAD
Satara
MAHARASHTRA
415110
India |
| Phone |
9960894773 |
| Fax |
|
| Email |
dimple2404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRASHANT PUNDE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KRISHNA VISHWA VIDYAPEETH, SCHOOL OF DENTAL SCIENCES , KARAD |
| Address |
The study would be performed in DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,ROOM NO.24 SCHOOL OF DENTAL SCIENCES, KRISHNA VISHWA VIDYAPEETH,
MALKPAUR, KARAD
Satara
MAHARASHTRA
415110
India |
| Phone |
8806149845 |
| Fax |
|
| Email |
pprashanta1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DIMPLE VIJAY CHAUDHARI |
| Designation |
MDS 3rd YEAR ORAL AND MAXILLOFACIAL SURGERY |
| Affiliation |
KRISHNA VISHWA VIDYAPEETH, SCHOOL OF DENTAL SCIENCES , KARAD |
| Address |
The study would be performed in DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,ROOM NO.24 SCHOOL OF DENTAL SCIENCES, KRISHNA VISHWA VIDYAPEETH,
Koyna vasahat
Satara
MAHARASHTRA
415110
India |
| Phone |
9960894773 |
| Fax |
|
| Email |
dimple2404@gmail.com |
|
|
Source of Monetary or Material Support
|
| KRISHNA VISHWA VIDYAPEETH, SDS, MALKAPUR, KARAD, MAHARASHTRA, INDIA 415110 |
|
|
Primary Sponsor
|
| Name |
KRISHNA VISHWA VIDYAPEETH |
| Address |
KVV,SDS, KARAD,MALKAPUR 415110 MAHARSHTRA, INDIA |
| 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 DIMPLE VIJAY CHAUDHARI |
KRISHNA VISHWA VIDYAPEETH DEEMED TO BE UNIVERSITY |
ROOM NO 24, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, SCHOOL OF DENTAL SCIENCES, KRISHNA VISHWA VIDYAPEETH DEEMED TO BE UNIVERSITY, MALKAPUR, KARAD
Satara
MAHARASHTRA |
9960894773
dimple2404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PLATELET RICH PLASMA |
PRP WILL BE PLACE ON SYMPHYSIS PARASYMPYSIS FRACTURE SITE AND BONE REGENERATION AND HEALING WOULD BE ASSESSED TILL 6 MONTH FOLLOW UP PERIOD AND WILL BE COMPARED WITH CONTROL GROUP
TOTAL DURATION WOULD BE 6 MONTHS |
| Comparator Agent |
PRP will not be placed in fracture site |
bone regeneration would be compared in fracture site |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with mandibular fractures, serum paltelet count above 1.5 lakhs, with no comorbidities |
|
| ExclusionCriteria |
| Details |
a) Fracture sites with signs of infection.
b) Patient with bone disease.
c) Medically compromised patients
d) Non-ambulatory patients
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOULD BE ASSESSED THROUGH EVALUATING BONE REGENERATION BY COMPARING STUDY WITH CONTROL GROUPS |
IMMEDIATE POST OPERATIVE PERIOD, 1 MONTH, 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WPULD BE ASSESSED AFTER 6 MONTHS |
IMMEDIATE POST OP, 1 MONTH, 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
07/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dimple2404@gmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 17-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a prospective, comparative, clinical study in patients with mandibular symphysis and/or parasymphysis fractures requiring Open Reduction Internal Fixation (ORIF) reporting to the Department of Oral and Maxillofacial Surgery, SDS, KVV, Karad. 20 patients with symphysis and parasymphysis fracture will be randomly divided into control and study groups. Only in study group patients PRP placement over fracture site will be done. All patients will be followed up for 6 months. Radiovisiography (RVG) will be taken of fracture site immediate postoperatively, 1 month and 6 months postoperatively. Radiographic intensity will be compared by using pixel size and resolution in Microsoft Paint Software at immediate post-operative, 1 month follow up and 6 month follow up period. Data will be statistically analysed. |