CTRI Number |
CTRI/2025/05/087724 [Registered on: 27/05/2025] Trial Registered Prospectively |
Last Modified On: |
26/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison and assessment of two materials derived from patients own blood in treating bone defects around gums and teeth |
Scientific Title of Study
|
Evaluation of Titanium Platelet Rich Fibrin and Advanced Platelet Rich Fibrin in Treatment of Periodontal Intrabony Defects: A Cone Beam Computed Tomography Analysis |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Iram khan |
Designation |
post graduate student |
Affiliation |
Institute of dental sciences Bareilly |
Address |
Department of Periodontology Room no 228
Institute of Dental sciences Pilibhit bypass road Bareilly
Bareilly UTTAR PRADESH 243006 India |
Phone |
7500410078 |
Fax |
|
Email |
iramkhanbds2020@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prerna Agarwal |
Designation |
Professor |
Affiliation |
INSTITUTE OF DENTAL SCIENCES BAREILLY |
Address |
Department of Periodontology
Institute of Dental Sciences Pilibhit Bypass Road Bareilly Uttar Pradesh 243006
Bareilly UTTAR PRADESH 243006 India |
Phone |
9927900055 |
Fax |
|
Email |
journalprerna@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prerna Agarwal |
Designation |
Professor |
Affiliation |
INSTITUTE OF DENTAL SCIENCES BAREILLY |
Address |
Department of Periodontology
Institute Of Dental Sciences
Pilibhit Bypass Road Bareilly Uttar Pradesh 243006
Bareilly UTTAR PRADESH 243006 India |
Phone |
9927900055 |
Fax |
|
Email |
journalprerna@gmail.com |
|
Source of Monetary or Material Support
|
Institute Of Dental Sciences Bareilly Uttar Pradesh 243006 |
|
Primary Sponsor
|
Name |
Institute of dental sciences Bareilly |
Address |
Institute of Dental sciences Pilibhit Bypass road Bareilly
Uttar Pradesh 243006 |
Type of Sponsor |
Other [Private Dental College] |
|
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 |
Iram khan |
Institute Of Dental Sciences Bareilly |
DEPARTMENT OF PERIODONTICS
ROOM NO 228
INSTITUTE OF DENTAL SCIENCES
PILIBHIT BYPASS ROAD
BAREILLY Bareilly UTTAR PRADESH |
07500410078
iramkhanbds2020@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE, IDS, BAREILLY, UP |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Advanced Platelet Rich Fibrin |
It is a type of platelet rich fibrin that contains higher concentration of leukocytes compared to standard PRF. It is said to be more refined version of PRF |
Intervention |
Titanium Platelet Rich Fibrin |
It is a platelet concentrate derived from blood prepared using titanium tubes to promote healing and bone regeneration |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
Individuals diagnosed with stage II or stage III periodontitis (AAP Classification of periodontitis 2017)
Age group of 20 to 55 years
Probing pocket depth more than equal to 5mm
Clinical attachment loss more than equal to 3mm
Radiographic evidence of intrabony defect |
|
ExclusionCriteria |
Details |
Systemically compromised patients
Patients who are on medications that may impede wound healing
Patients who are smokers
Pregnant and lactating females |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Mean gain in bone volume |
baseline and 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
pocket probing depth reduction
relative attachment level gain |
baseline and 6 months |
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
10/06/2025 |
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 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
|
Periodontitis is a multifactorial disease characterized by the irreversible loss of connective tissue attachment and supporting alveolar bone. The ultimate goal pertaining to periodontal therapy is to control the active inflammation and the reconstruction of the structure lost due to periodontal disease. PRF stimulates the vascular system and promotes angiogenesis, releases growth factors such as vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), insulin-like growth factor (IGF), and transforming growth factor (TGF) that are involved in tissue regeneration. Although PRF has shown promising clinical results, some experts are worried about potential health risks because it uses glass evacuated collection tubes for blood with silica activators. Tunali M. et al. created a novel platelet concentrate in 2013 called titanium-prepared, platelet-rich fibrin (T-PRF). The preparation technique is predicated on the idea that titanium tubes, as opposed to the glass tubes utilized in Choukroun’s method, could be more successful at activating platelets. In 2014, Ghanaati et al. introduced a new modification called Advanced-PRF (A-PRF), which matrices in their solid form, utilizes a low-speed centrifugation protocol. This method offers the additional advantage of evenly distributed cells, promoting effective regeneration. Hence, this study is designed to compare and evaluate the effectiveness of T-PRF and A-PRP clinically and radiographically (using cone beam computed tomography) in the management of periodontal intrabony defects. |