| CTRI Number |
CTRI/2023/12/060880 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Comparison of effectiveness of human amniotic membrane to platelet rich fibrin in healing of post extraction sockets. |
|
Scientific Title of Study
|
“COMPARISON OF EFFECTIVENESS OF HUMAN AMNIOTIC
MEMBRANE TO PLATELET RICH FIBRIN IN HEALING OF POST
EXTRACTION SOCKETS-A RANDOMISED CONTROLLED TRIAL" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Ashwini |
| Designation |
Post graduate Student |
| Affiliation |
RVS Dental College and Hospital |
| Address |
RVS Dental College & Hospital
Kumaran Kottam campus kannampalayam sulur Coimbatore
Coimbatore
TAMIL NADU
641402
India |
| Phone |
9655695895 |
| Fax |
|
| Email |
ashujadhav1930@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vigneswaran T |
| Designation |
Head of the department and professor |
| Affiliation |
RVS Dental College and Hospital |
| Address |
RVS Dental College & Hospital
Kumaran Kottam campus kannampalayam sulur Coimbatore
Coimbatore
TAMIL NADU
641402
India |
| Phone |
9600400414 |
| Fax |
|
| Email |
dratvignesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Ashwini |
| Designation |
Post graduate Student |
| Affiliation |
RVS Dental College and Hospital |
| Address |
RVS Dental College & Hospital
Kumaran Kottam campus kannampalayam sulur Coimbatore
Coimbatore
TAMIL NADU
641402
India |
| Phone |
9655695895 |
| Fax |
|
| Email |
ashujadhav1930@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amniotic Membrane-Tata Memorial Tissue Bank-Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr.A.Ashwini |
| Address |
RVS Dental College & Hospital
Kumaran Kottam campus kannampalayam sulur Coimbatore
Pin No 641402 |
| 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 A Ashwini |
RVS Dental college and Hospital, Coimbatore |
Department of oral and maxillofacial surgery,Kumaran Kottam Campus,Kannampalayam,Sulur.641402 Coimbatore.
Coimbatore
TAMIL NADU |
9655695895
ashujadhav1930@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RVS INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PAIN IN TEETH |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amniotic membrane to plasma rich fibrin |
Test Group A- Amniotic membrane placed in socket and Sutured -20 Patients.
Test Group B- PRF placed in socket -20 Patients.
|
| Intervention |
Amniotic membrane to plasma rich fibrin |
Test Group A- Amniotic Membrane placed in socket and Sutured -20 Patients.
Test Group B- PRF placed in socket -20 Patients.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age ≥18 years
Non-smokers
Presenting with teeth indicated for atraumatic extraction due to Dental caries or periodontitis.
COVID Negative individuals
Patient who has to undergo extraction of single/ multiple teeth in more than one quadrant
ASA I, ASA II
|
|
| ExclusionCriteria |
| Details |
Immune compromised
Pregnant & Lactating women
Non-cooperative
History of allergy.
Infectious diseases.
Any other uncontrolled systemic conditions -.ASA III, ASA IV
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS PAIN SCORE, SWELLING ASSESSMENT,SOFT TISSUE HEALING ASSESSMENT-LAUNDRY-TURBELL HOWLEY INDEX, MOUTH OPENING |
DAY 1, DAY 3 AND DAY 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SWELLING ASSESSMENT,MOUTH OPENING |
DAY 1, DAY 3 AND DAY 7 |
|
|
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 1 |
|
Date of First Enrollment (India)
|
26/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
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
|
"The aim of
this randomized controlled trial is to compare the effectiveness of human
amniotic membrane (HAM) to platelet-rich fibrin (PRF) in facilitating the
healing process of post-extraction sockets among dental patients. This study
will assess and analyze the clinical outcomes, including pain management,
inflammation reduction, soft tissue healing, and to determine which
regenerative therapy, HAM or PRF, yields superior results in optimizing
post-extraction socket healing."
OBJECTIVES:
1. To evaluate and
compare the postoperative pain levels experienced by patients treated with HAM
and PRF in post-extraction sockets.
2. To assess and
compare the degree of postoperative inflammation in the extraction sockets
between the HAM and PRF treatment groups.
3. To measure and
compare the rate of soft tissue healing in post-extraction sockets treated with
HAM and PRF.
4. To investigate
and compare the incidence of complications, such as infection or adverse
reactions, associated with HAM and PRF treatments in post-extraction sockets.
|