| CTRI Number |
CTRI/2020/12/029963 [Registered on: 21/12/2020] Trial Registered Prospectively |
| Last Modified On: |
19/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Advanced and titanium platelet rich fibrin for treating intrabony defects. |
|
Scientific Title of Study
|
Evaluation of Intrabony Defects treated with Advanced and Titianium enriched Platelet Rich Fibrin. An In Vivo Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| agarwalmanvi25@gmail.com |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Gaba |
| Designation |
post graduate |
| Affiliation |
Institute of dental sciences |
| Address |
Department of periodontology and implantology Institute of dental sciences department of periodontology and implantology near pilibhit bypass room number-54 Pg2 Ruhailkhand medical college
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8958683345 |
| Fax |
|
| Email |
dranjaligaba4531@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manvi Chandra Agarwal |
| Designation |
Professor |
| Affiliation |
Institute of dental sciences |
| Address |
Institute of dental sciences department of periodontology and implantology near pilibhit bypass
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9457540800 |
| Fax |
|
| Email |
agarwalmanvi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manvi Chandra Agarwal |
| Designation |
Professor |
| Affiliation |
|
| Address |
Institute of dental sciences department of periodontology and implantology near pilibhit bypass
UTTAR PRADESH
243006
India |
| Phone |
9457540800 |
| Fax |
|
| Email |
agarwalmanvi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Dr Anjali Gaba |
| Address |
Institute of dental sciences department of periodontology and implantology near pilibhit bypass |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manvi Agarwal |
Institute of dental sciences department of periodontology and implantology near pilibhit bypass |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Gaba |
institiute of dental sciences |
Institute of dental sciences department of periodontology and implantology near pilibhit bypass
Bareilly
UTTAR PRADESH |
8958683345
dranjaligaba4531@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
systemically healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Advanced platelet rich fibrin |
A-PRF is a platelet rich concetrate used for intrabony defect treatment |
| Intervention |
Titanium platelet rich fibrin |
TPRF is a platelet rich concentrate centrifuged in titanium tubes for treating intrabony defects. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
55.00 Day(s) |
| Gender |
Both |
| Details |
Patients having minimum of 20 permanent teeth.
Age group of 20 to 55 years.
Probing pocket depth ≥ 5mm.
Clinical attachment loss ≥3mm.
Radiographic evidence of intrabony defect.
|
|
| ExclusionCriteria |
| Details |
Systemically compromised patients.
Patients who are on medications that could interfere with wound healing.
Patients with grade III mobility.
Chronic smokers and alcoholics.
Pregnant and lactating females.
Patients who had undergone periodontal treatment with in a period of last 1 year
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate and compare clinical and radiographic outcome of Advanced Platelet - rich fibrin (A-PRF + bone graft) and Titanium Platelet-rich fibrin (T PRF + bone graft) in the treatment of intrabony defect resulting from periodontal disease. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the clinical and radiographic outcome after performing periodontal regenerative therapy with A-PRF
To evaluate the clinical and radiographic outcome after performing periodontal regenerative therapy with T-PRF
To compare both the procedures and to find out any possible difference in the two.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/12/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
present study has been designed as a prospective controlled clinical trial. The
study will include suitable number of patients referred for treatment of
chronic periodontitis to the Department of Periodontology, Institute of Dental
Sciences, Bareilly.
All
participants will be informed about the risks and benefits of the procedure and
signed informed consent were taken from them.
Clinical
parameters and radiographic parameters will be recorded at different points of
time i.e. at baseline, 3 months and 6 months.
After recording clinical parameters and administering
phase-1 therapy, the site will be decided by tossing the coin and treated
either with A-PRF or T-PRF along with bone graftafter raising a full thickness
flap and debridement.
Group
A: Flap surgery with A- PRF + Hydroxyapatite and Tricalcium phosphate (TCP)
Group
B: Flap surgery with T- PRF+ Hydroxyapatite and Tricalcium phosphate (TCP)
The
A-PRF is made in a glass tube as per procedures by Kobayashi et al (2014).
The
T-PRF is made in a titanium test tube that is of medical grade titanium as per
procedures by Mustafa Tunali et al (2011).
|