| CTRI Number |
CTRI/2026/03/105554 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Local delivery of blood derived proteins into the gums after deep cleaning to improve gum diseases. |
|
Scientific Title of Study
|
Evaluation Of The Adjunctive Use Of Albuminated Platelet Rich Fibrin (Alb-PRF) Versus Injectable Platelet Rich Fibrin (i-PRF) In Non-Surgical Periodontal Therapy: A Split-Mouth Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samyukdha S K |
| Designation |
post graduate student |
| Affiliation |
SRM Dental college |
| Address |
Department of Periodontology, SRM Dental college, Bharathi salai, Ramapuram, Chennai, 600089.
Chennai
TAMIL NADU
600089
India |
| Phone |
7358858808 |
| Fax |
|
| Email |
samyukdhakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM Dental college |
| Address |
Department of Periodontology,
SRM Dental college, Bharathi salai, Ramapuram, Chennai, 600089.
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anupama Tadepalli |
| Designation |
Professor |
| Affiliation |
SRM Dental college |
| Address |
Department of Periodontology,
SRM Dental college, Bharathi salai, Ramapuram, Chennai, 600089.
Chennai
TAMIL NADU
600089
India |
| Phone |
9677065517 |
| Fax |
|
| Email |
anupamamds@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Samyukdha S K |
| Address |
Department of Periodontology,
SRM Dental College, Bharathi Salai, Ramapuram, Chennai, 600089 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM Dental College |
SRM Dental College, Bharathi Salai, Ramapuram, Chennai, 600089 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anupama Tadepalli |
SRM Dental College |
4th floor, Department of Periodontology,
SRM Dental College, Bharathi Salai, Ramapuram, Chennai, 600089
Chennai
TAMIL NADU |
9677065517
anupamamds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Review Board SRM Dental College |
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 |
| Intervention |
Albuminated Platelet Rich Fibrin |
Venous blood will be collected in sterile tubes without anticoagulant and immediately centrifuged. The platelet-poor plasma (PPP) will be separated and subjected to controlled heat treatment to form autologous albumin gel. After cooling, this gel will be mixed with the remaining liquid PRF fraction to obtain albuminated PRF (Alb-PRF), producing a biologically stable fibrin matrix with extended working time. The prepared Alb-PRF will then be injected subgingivally into periodontal pockets using a sterile syringe with a blunt cannula in an apico-coronal direction to ensure uniform distribution up to the pocket entrance. |
| Comparator Agent |
Injectable Platelet Rich Fibrin
|
Venous blood will be collected in manufacturer-specified tubes without anticoagulant and immediately centrifuged. The upper liquid PRF layer will be aspirated for use. As injectable-PRF remains in liquid form briefly before polymerizing into a fibrin gel, it allows adequate clinical handling time. The prepared i-PRF will be delivered subgingivally into periodontal pockets using a syringe with a blunt cannula in an apico-coronal direction until the pocket entrance is reached. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy adults aged 25 to 65 years, of either gender
2.Periodontitis individuals with presence of bilateral periodontal pockets involving at least 2 interproximal sites in the posterior teeth maxilla or mandible suitable for split mouth allocation.
3.Presence of a minimum of 20 natural teeth overall, with at least 4 teeth in the quadrant of interest.
4.Patients who are willing to participate, provide written informed consent and comply with study procedures and scheduled follow up visits.
|
|
| ExclusionCriteria |
| Details |
1.History of periodontal therapy within the previous 6 months.
2.History of use of antibiotics, anti inflammatory drugs, corticosteroids, or immunosuppressive therapy within the last 3 months.
3.Sites with grade four furcation involvement , or grade two and three mobility.
4.Teeth with endodontic lesions or restorations or serving as abutments for FPD.
5.Individuals with known systemic diseases or conditions that may affect periodontal status or wound healing .
6.History of bleeding disorders or use of antiplatelet or anticoagulant therapy.
7.Smokers or users of any form of tobacco.
8.Pregnant or lactating women.
9.Individuals with poor oral hygiene compliance.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Periodontal Probing Depth
2. Clinical Attachment Level |
Baseline,1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
31/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Platelet-Rich Fibrin (PRF) is a second-generation autologous platelet concentrate commonly used in regenerative dentistry because it improves wound healing and tissue repair. It is made without anticoagulants or added chemicals, making it a simple, cost-effective, and biologically safe option. PRF includes a fibrin matrix rich in platelets and leukocytes, which gradually release growth factors. This supports soft tissue healing, new blood vessel formation, and periodontal regeneration. In periodontology, PRF has become important as a supplement to both surgical and non-surgical treatments because it promotes tissue repair and reduces inflammation. With improvements in centrifugation methods, new PRF formulations have been created to enhance handling and biological effectiveness. Injectable Platelet-Rich Fibrin (i-PRF) is a liquid version obtained through low-speed centrifugation. Its injectable form allows for easy delivery into periodontal pockets after scaling and root planing. It solidifies after application, forming a fibrin network at the site and improving healing and tissue response in non-surgical periodontal therapy. Albuminated Platelet-Rich Fibrin (Alb-PRF) is a modified version of PRF that adds thermally treated albumin to the fibrin matrix. This change aims to improve structural stability and extend its absorption time. It is believed to offer a longer-lasting regenerative effect and better support properties compared to standard liquid PRF. While both i-PRF and Alb-PRF show potential for regeneration, there is limited clinical evidence comparing their effectiveness as supplements in non-surgical periodontal therapy. Therefore, this split-mouth randomized clinical trial seeks to evaluate and compare the use of Alb-PRF and i-PRF in patients undergoing non-surgical periodontal treatment. The findings of this study will help assess the relative clinical effectiveness of Alb-PRF and i-PRF as supplements to non-surgical periodontal therapy. This will also support evidence-based decision-making in periodontal practice |