| CTRI Number |
CTRI/2025/09/094124 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing and finding new approaches for treating bone loss problem in gum diseases. |
|
Scientific Title of Study
|
Multimodal diagnostic evaluation of the combined efficacy of advanced-platelet rich fibrin and demineralized bone matrix of type one collagen versus their individual assessment in the management of periodontal intrabony defects - a clinico-radiographic and immunological 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 |
Dr Sanjana TS Rao |
| Designation |
Post graduate student |
| Affiliation |
Rajarajeswari dental college and hospital |
| Address |
Department of periodontology Room number 4,Rajarajeswari dental college and hospital,ramohalli cross,mysore road bangalore Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
8951240090 |
| Fax |
|
| Email |
drsanjanatsrao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RS Senthil Rajan |
| Designation |
Professor |
| Affiliation |
Rajarajeswari dental college and hospital |
| Address |
Department of periodontology Room number 4,Rajareajeswari dental college and hospital,ramohalli cross,mysore road bangalore Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
9036943516 |
| Fax |
|
| Email |
senthilrajanrs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjana TS Rao |
| Designation |
Post graduate student |
| Affiliation |
Rajarajeswari dental college and hospital |
| Address |
Department of periodontology Room number 4,Rajarajeswari dental college and hospital,ramohalli cross,mysore road bangalore Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
8951240090 |
| Fax |
|
| Email |
drsanjanatsrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari dental college and hospital,
ramohalli cross, kumbalgodu, mysore road, bangalore-560074, karnataka, India.
|
|
|
Primary Sponsor
|
| Name |
Dr Sanjana TS Rao |
| Address |
Department of periodontology Room number 4,Rajarajeswari dental college and hospital,ramohalli cross,mysore road bangalore Karnataka |
| 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 |
| Dr Sanjana TS Rao |
Rajarajeswari dental college and hospital |
Department of periodontology Room number 4
Bangalore
KARNATAKA |
08951240090
drsanjanatsrao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Advanced platelet rich fibrin |
intervention for 3 6 months |
| Intervention |
Advanced platelet rich fibrin and xenograft |
intervention for 3 6 months |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Xenograft |
intervention for 3 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Presence of intrabony defects with less than or equal to 3mm deep (the distance between the alveolar crest and base of defect) on intraoral periapical radiograph [IOPA]along with interproximal probing depth [PD] less than or equal to 5mm after phase 1 therapy.
Patients with no history of allergy to materials and drugs used or prescribed in this study
|
|
| ExclusionCriteria |
| Details |
Patients who have undergone periodontal treatment within a period of 1 year.
Patients on any medication taken within the last 6 months which may alter the periodontal status.
Chronic smokers and alcoholics.
Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The combined efficacy of advanced-platelet rich fibrin and demineralized bone matrix of type one collagen is expected to show better results when compared to the groups where each component is assessed individually. |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 4 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="2"
Months="0"
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
|
Chronic periodontitis is an infectious disease caused by bacteria in dental plaque, leading to destruction of gingiva, periodontal ligament, cementum, and alveolar bone, and progresses with phases of exacerbation and remission, affecting nearly 50% of the global population with 1.1 billion severe cases reported in 2019. Management includes non-surgical therapy such as scaling, root planing, and oral hygiene instruction to control inflammation, while surgical interventions are required for persistent deep pockets and bone loss. Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate introduced by Choukroun et al. in 2001, and its modifications like injectable PRF (i-PRF) and advanced PRF (A-PRF, introduced in 2014 using low-speed centrifugation) enhance regeneration by releasing higher amounts of growth factors, though further validation is needed. PRF combined with xenogenic bone substitute materials (XBSM), particularly bovine-derived hydroxyapatite-based xenografts which are osteoconductive but non-osteogenic, has shown superior outcomes in intrabony defect treatment with improved probing depth reduction, attachment gain, and defect fill. Periodontal disease progression is mediated by inflammation characterized by vascular changes and accumulation of leukocytes, cytokines, and interleukins, with IL-6—produced by immune cells—detected at higher levels in inflamed gingiva and gingival crevicular fluid of periodontitis patients. Against this background, the present study aims to compare the combined efficacy of A-PRF and xenografts versus their individual applications in periodontal defect regeneration through both clinical and molecular assessments.
All patients will undergo scaling, root planing and oral hygiene instructions will be given. Measurements for clinical parameters will be recorded by a single investigator. The cases will then be re-evaluated. Out of 36 intrabony defects,12 intrabony defects will be treated with a combined block of A-PRF and xenograft (colocast®) and 12 intrabony defects will be treated with A-PRF alone and the other 12 intrabony defects will be treated with the xenograft (colocast®) alone as a regenerative material. During surgery, 10 mL of intravenous blood will be drawn from the antecubital vein and collected in a syringe without anticoagulant. The blood sample will then be immediately centrifuged at – 1300 rpm for 8 minutes using a Remi Medico Centrifuge. After centrifugation, the fibrin clot will be carefully removed from the tube and separated using microsurgical scissors. Advanced Platelet-rich fibrin (A-PRF) will then be obtained in the form of a membrane by gently squeezing out the fluids from the fibrin clot. The surgical technique will be performed under local anesthesia. The post-operative evaluation and data collection will be done at 3 and 6 months. The clinical parameters to be recorded are: Soft tissue parameters · Pocket depth (from gingival margin to base of the pocket) · Clinical attachment level Hard tissue parameters: · Radiographic analysis of linear bone growth and % of bone fill. Standardized radiographs of the defect sites will be taken using IOPAR film grids to measure the amount and density of bone fill. The Immonological analysis will involve measuring IL-6 levels in gingival crevicular fluid (GCF) using an ELISA kit. Approximately 3µl of GCF samples will be collected, at baseline and 6 months ,using microcapillary pipettes which will be wrapped in tin foil and placed in cryovial sealed with parafilm and stored at -80oC until analysis. The quantification will be performed with the Multiskan GoTM microplate spectrophotometer from Thermo Scientific, ensuring precise and reliable assessment of IL-6 concentration in the samples. The samples will be processed in Central Research Laboratory, RRMCH, Bangalore. |