| CTRI Number |
CTRI/2019/09/021109 [Registered on: 06/09/2019] Trial Registered Prospectively |
| Last Modified On: |
04/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of post operative healing of extraction socket with calcium chloride activated platelet rich plasma |
|
Scientific Title of Study
|
Comparison of post operative healing of extraction socket with and without calcium chloride activated platelet rich plasma-an invivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aneesha s |
| Designation |
Postgraduate |
| Affiliation |
Kerala Dental Council (No 13455) |
| Address |
OMFS PG Student
Department of Oral and Maxilofacial Surgery
Sree Mookambika Institute of Dental Science
Padanilam, Kulashekharama
OMFS PG Student
Department of Oral and Maxilofacial Surgery
Sree Mookambika Institute of Dental Science
Padanilam, Kulashekharama
Kanniyakumari
TAMIL NADU
280745
India |
| Phone |
08547148230 |
| Fax |
|
| Email |
aneesha2009in28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mathew Jose |
| Designation |
Head of the Department |
| Affiliation |
Kerala Dental Council |
| Address |
Head of the Department
Oral and Maxilofacial Surgery Department
Sree Mookambika Institute of Dental Science
Kulashekharam padanilam
Head of the Department
Oral and Maxilofacial Surgery Department
Sree Mookambika Institute of Dental Science
Kulashekharam padanilam
Kanniyakumari
TAMIL NADU
280745
India |
| Phone |
9447525297 |
| Fax |
|
| Email |
matjosein@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Aneesha s |
| Designation |
Postgraduate |
| Affiliation |
Kerala Dental Council |
| Address |
Postgraduate Student
Oral and Maxilofacial Department
Sree Mookambika Institute of Dental Science
Kulashekharam Padanilam
Postgraduate Student
Oral and Maxilofacial Department
Sree Mookambika Institute of Dental Science
Kulashekharam Padanilam
Kanniyakumari
TAMIL NADU
280745
India |
| Phone |
08547148230 |
| Fax |
|
| Email |
aneesha2009in28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Only
Dr Aneesha S
Postgratuate Student
Oral & Maxilofacial Department
Sree Mookambika Institute of Dental Science
Padanilam Kulashekharam
I am doing this thesis from my own funds and I am not having any other sponsoring for the same. |
|
|
Primary Sponsor
|
| Name |
AneeshaS |
| Address |
ABHAYAM
Convant Lane pallimukku
Peyad Trivandrum 695 573 |
| 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 |
| AneeshaS |
Sree Mookambika Institute of Dental Science |
Oral and Maxilofacial Surgery Department sree mookambika institute of dental science, kulashekaram,kanyakumari dist
kulasekharam
Kanniyakumari
TAMIL NADU |
8547148230
aneesha2009in28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with out any systemic illness
no h/o immunodeficiency patholgy,psychiatric problems,platelet or hematological disorders,not undergoing chemotherapy or radiotherapy. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIl |
NIl |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients who needs bilateral similar tooth extraction
Patients who will agreed for this study |
|
| ExclusionCriteria |
| Details |
Chain smoker
Uncontrolled systemic illness
Immunodeficiency pathology
Patient with psychiatric problem
Pregnant patient
Platelet and hematological disorders
Chemotherapy and radiotherapy patients
Who needes surgical removal of tooth |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The placement of calcium chloride activated platelet rich plasma gel in the extraction site will improve the healing property of tissue and faster wound healing |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will help for bone formation in extraction socket, which will benefit for prosthetic rehabilitation. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/07/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1. Shubha Ranjan Dutta;Mandibular Third Molar Extraction Wound Healing
With and Without Platelet Rich Plasma: A Comparative Prospective Study.
J. Maxillofac. Oral Surg. 2015; 14:808–815.
2. Robert E. Marx;Platelet-Rich Plasma: Evidence to Support Its Use. J Oral Maxillofac Surg.2004;62:489-496.
3. Ruchi Pathak Kaul ;Autologous Platelet Rich Plasma After Third Molar Surgery:
A Comparative Study. J. Maxillofac. Oral Surg.2012;119(2):200–5
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Platelet rich plasma (PRP) is a new approach to tissue regeneration and it is becomming a valuable adjunt to promote healing in many procedures in dental and oral surgery. PRP derives from the centrifugation of the patients own blood and it contains growth factors that influence wound healing.Placement of PRP in extraction socket improve wound healing and bone formation. PRP can be activated to form PRP gel thus cause degranulation of alpha granules present in platelets and releasing growth factors.Here I am using calcium chloride 10% solution for PRP activation to form gel and it is placed in extraction of case patients and evaluated for 3rd day 7th day and 14th day for clinical wound healing evaluation and 1st month and 3rd month for radiographic examination. This prospective clinical trial is designed to compare bone filling and soft tissue healing with and without calcium chloride activated PRP in bilateral similar tooth extraction patients. |