| CTRI Number |
CTRI/2024/01/061891 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
In-vitro study |
| Study Design |
Other |
|
Public Title of Study
|
Titanium Platelet Rich Fibrin injected with antibiotics and herbal extract seperately a lab study |
|
Scientific Title of Study
|
Evaluating the anti-microbial efficacy and drug kinetics of Titanium Platelet Rch Fibrin (T-PRF) loaded with Amoxicillin+ Clavulanic acid gel, Metronidazole gel and Neem gel: An In-vitro study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiva Shankar Gummaluri |
| Designation |
senior lecturer |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Dept of Periodontics
GITAM Dental College and Hospital
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9703647979 |
| Fax |
|
| Email |
sivashankar.gummaluri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shiva Shankar Gummaluri |
| Designation |
senior lecturer |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Dept of Periodontics
GITAM Dental College and Hospital
ANDHRA PRADESH
530045
India |
| Phone |
9703647979 |
| Fax |
|
| Email |
sivashankar.gummaluri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Trinath Kishore Damera |
| Designation |
Professor and Head |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Dept of Periodontics
GITAM Dental College and Hospital
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9949109930 |
| Fax |
|
| Email |
dentalcys@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Shiva Shankar Gummaluri |
| Address |
Dept of Periodontics
GITAM Dental College and Hospital |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self funded |
self funded by author |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiva Shankar Gummaluri |
GITAM Dental College and Hospital |
Room No 6, Dept of Periodontics
Visakhapatnam
ANDHRA PRADESH |
9703647979
sivashankar.gummaluri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
systemically healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NIl |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
subjects who were systemically healthy, willing to participate in study, having greater than 2 lakhs platelets, who do not have any systemic disease |
|
| ExclusionCriteria |
| Details |
subjects under any sought of medications, subjects not willing to take part, smoking, lactating and pregnant females, subjects having any systemic illness were eliminated |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| drug kinetics and anti-microbial efficacy |
drug kinetics at 0,2, 24, 48, 72 hours and anti-microbial efficacy at 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| scanning electron microscopy & FT-IR |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "11"
Final Enrollment numbers achieved (India)="11" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2024 |
| Date of Study Completion (India) |
30/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sivashankar.gummaluri@gmail.com].
- For how long will this data be available start date provided 30-04-2024 and end date provided 31-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
20 healthy volunteers will be recruited based on proper inclusion and exclusion criteria and 20 ml of blood will be drawn for anticubital vein. Further T-PRF membrane clots will be prepared by Tunali M et al 2013 protocol and to it Amoxicillin+clavulanate gel, metronidazole gel, neem gel will be incorporated individually and subjected to Drug kinetics analysis and antimicrobial efficacy. Drug kinetics will be checked through spectrophotometric analysis at 0, 2, 24, 48 and 72 hours. Antimicrobial efficacy checked as zone of inhibition diameters at 48 hours.
|