| CTRI Number |
CTRI/2025/08/093945 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the benificial effects of two types of blood-based treatments when added to deep dental cleaning for people with moderate gum disease |
|
Scientific Title of Study
|
Clinical efficacy of Albumin Prf and injectable Prf as an adjunct to scaling and root planing in the management of stage 2 periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chennuru Sree ramya |
| Designation |
PG student |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences Takkellapadu, guntur
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9121799309 |
| Fax |
|
| Email |
sreeramyachennuru@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr D Ravindranath |
| Designation |
Professor & HOD |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences, Takkellapadu, guntur
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9849222259 |
| Fax |
|
| Email |
ravident69@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Chennuru Sree ramya |
| Designation |
PG student |
| Affiliation |
Sibar institute of dental sciences guntur |
| Address |
Room no 8, department of periodontology, Sibar institute of dental sciences Takkellapadu, guntur
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9121799309 |
| Fax |
|
| Email |
sreeramyachennuru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental Sciences, takkellapadu, guntur, Andhra pradesh, India,522509
|
|
|
Primary Sponsor
|
| Name |
Chennuru Sree ramya |
| Address |
Room no 8,department of periodontology,sibar institute of dental sciences, takkellapadu, Guntur, Andhra pradesh, India,522509
|
| 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 |
| DrChennuru Sree ramya |
Sibar institute of dental sciences |
Room no 8, 2nd floor, department of periodontology, sibar institute of dental sciences, takkellapadu, Guntur 522509 Guntur ANDHRA PRADESH |
9121799309
sreeramyachennuru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sibar institute of dental sciences |
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 |
Albumin Prf |
2ml of Albumin prf is applied locally immediately after scaling and root planing |
| Comparator Agent |
Injectable prf |
2ml of Injectable prf is applied locally immediatewly after scaling and root planing |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are apparently healthy.
Presence of at least 20 teeth
Subjects with Stage 2 periodontitis
Subjects who are willing to give informed consent |
|
| ExclusionCriteria |
| Details |
History of previous antibiotic therapy within the past 3 months
Periodontal treatment in last 6 months.
Pregnant woman and Lactating mothers.
Any form of tobacco use
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Clinical attachment level |
After 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of probing depth, Plaque & gingival index |
At baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
15/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - NO
|
|
Brief Summary
|
This study is a
randomized, parallel group clinical trial comparing the efficacy of AlbuminPrf and injectable Prf as an adjunct to
scaling and root planing in the management of stage 2 periodontitis patients. In 2015, injectable platelet rich
fibrin was developed and initially studied using a short, slow
centrifugation protocol. This method allowed injectable PRF to remain in liquid form for
approximately 15 to 20 minutes. The formulation was utilized in various procedures,
including its combination with bone grafts to create a stable fibrin graft
matrix, enhancing handling and graft stability. To address the stability
limitations of platelet concentrates, a new process was introduced that
involves combining the liquid portion of liquid PRF with denatured platelet poor
plasma. This formulation was initially termed Albumin Concentrated albumin with the
presence of a concentrate of growth factors, offering improved stability and
extended clinical applicability.The process was later renamed
AlbuminPRF albumin with liquid PRF.The incorporation of denatured serum albumin
significantly strengthens the PRF based scaffold, resulting in an autologous,
biocompatible material with improved stability and prolonged therapeutic
effects.
Group 1: Albumin Prf after Scaling and root planing
Group 2: injectable Prf after Scaling and root planing
Primary and secondary outcomes will be measured
at baseline and after 3 months |