| CTRI Number |
CTRI/2025/03/081739 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can Aspirin Boost Bone Regeneration? Exploring its role in enhancing L-PRF Blocks for bone regeneration in periodontal disease Treatment |
|
Scientific Title of Study
|
Does Aspirin enhance the regenerative capacity of L-PRF Block in the treatment of intrabony defects. A parallel design, double arm, non-inferiority 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 |
DR ATHIYA FATHIMA A |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BANGALORE INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY
ROOM NO.- 5
BANGALORE INSTITUTE OF DENTAL SCIENCES
5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9486482686 |
| Fax |
|
| Email |
docathiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S SRIRANGARAJAN |
| Designation |
Head of department. |
| Affiliation |
BANGALORE INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of periodontology
Room no.5
Bangalore institute of dental sciences
5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru
KARNATAKA
560027
India |
| Phone |
9486482686 |
| Fax |
|
| Email |
docranga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ATHIYA FATHIMA A |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BANGALORE INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of periodontology
Room no.5
Bangalore institute of dental sciences
5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru
KARNATAKA
560027
India |
| Phone |
9486482686 |
| Fax |
|
| Email |
docathiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore institute of dental sciences
Department of periodontology
Room no-5
5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560027 |
|
|
Primary Sponsor
|
| Name |
DR ATHIYA FATHIMA A |
| Address |
5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560027 |
| 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 Athiya Fathima A |
Bangalore institute of dental sciences |
Department of periodotology Room no. 5
5/3, Hosur Main Road, adjacent to Nimhans Convention Centre, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560027
Bangalore
KARNATAKA |
9486482686
docathiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee BANGALORE INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
L-PRF BLOCK |
10 ml blood will be obtained from patient. One Vacutainer containing 3ml blood will be placed in a swing rotor centrifuge. Centrifugation will be done at 2700 rpm for 3 minute,(Yellow fluid)Liquid fibrinogen will be obtained on top which will be aspirated into syringe
Another vacutainer containing blood will be centrifuged at 2700 rpm for 12 minutes, the clot will be removed and red cells will be separated. The clot will be compressed into L-PRF membrane . The L-PRF membrane will be chopped into small pieces. The chopped membranes will be mixed with bone substitute (1:1 ratio). 1ml of liquid fibrinogen will be added and stirred for approximately 5 seconds while shaping it to desired form. This L-PRF Block formed will be placed into the debrided intrabony defect site. |
| Comparator Agent |
L-PRF BLOCK with Aspirin |
10 ml blood will be obtained from patient. One Vacutainer containing 3ml blood will be placed in a swing rotor centrifuge. Centrifugation will be done at 2700 rpm for 3 minute,(Yellow fluid)Liquid fibrinogen will be obtained on top which will be aspirated into syringe Another vacutainer containing blood with aspirin will be centrifuged at 2700 rpm for 15-18 minutes, the clot will be removed and red cells will be separated. The clot will be compressed into L-PRF membrane . The L-PRF membrane will be chopped into small pieces. The chopped membranes will be mixed with bone substitute (1:1 ratio). 1ml of liquid fibrinogen will be added and stirred for approximately 5 seconds while shaping it to desired form. This L-PRF Block with aspirin formed will be placed into the debrided intrabony defect site |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
STAGE 3 GRADE A PERIODONTITIS PATIENTS
BOP More than 15% bleeding sites.
Minimum of 20 teeth, excluding third molars to be present.
Patients with good general health.
Non-smokers.
|
|
| ExclusionCriteria |
| Details |
Any systemic or debilitating disease affecting periodontal and bone health (e.g., Diabetes).
Immunocompromised patients (HIV infected).
Regular anti-inflammatory medication use (NSAIDS or Aspirin).
Regular intake of any medication that affects bone metabolism (vitamin D supplements).
Antimicrobial use in the last three months.
Surgical periodontal treatment in the last six months.
Teeth with root caries (active or filled).
Endodontically treated teeth.
Allergy to aspirin.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RADIOGRAPHIC PARAMETER OF VERTICAL DEFECT ON CBCT |
BASELINE (0 MONTH)
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival index ( Loe and Silness 1963)
Plaque index (Turesky-Gilmore-Glickman modification of Quigley Hein plaque index 1970)
Probing pocket depth
Clinical attachment level
Relative attachment level
|
Baseline
1 MONTH
3 MONTH
6 MONTH |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/03/2025 |
| 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
|
To evaluate the clinical and radiographic outcomes of Open Flap Debridement with L-PRF block. To evaluate the clinical and radiographic outcomes of Open Flap Debridement with L-PRF Block and Aspirin. To comparatively evaluate the clinical and radiographic outcomes of Open Flap Debridement with L-PRF Block, with or without the addition of Aspirin in the treatment of intrabony vertical defects
|