| CTRI Number |
CTRI/2025/08/092167 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the Effectiveness of a Gel Containing Aspirin and Erythropoietin in Treating Bone Defects Around Teeth |
|
Scientific Title of Study
|
Clinical efficacy of Aspirin and Erythropoietin loaded injectable hydrogels as a Local Drug Delivery system in the treatment of intrabony defects a Randomized control 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 ASMA ANJUM I |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Bangalore Institute of Dental Sciences |
| Address |
Department of Periodontology, Bangalore Institute of Dental Sciences, 3rd Floor, Room No. 5, 5/3 Hosur main road adjacent to Nimhans convention center, Lakkasandra, Wilson Garden, Bengaluru Karnataka 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
8220328833 |
| Fax |
|
| Email |
anjujannat10299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SRIKUMAR PRABHU K |
| Designation |
Reader |
| Affiliation |
Bangalore Institute of Dental Sciences |
| Address |
Bangalore institute of dental science, Department of Periodotology,3rd floor,room no 5,5/3 Hosur Main Road, adjacent to Nimhans Convention Centre Lakkasandra Wilson Garden Bengaluru Karnataka 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9845009397 |
| Fax |
|
| Email |
dr_ksrikumar@yahoo.co,in |
|
Details of Contact Person
Public Query
|
| Name |
DR ASMA ANJUM I |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Bangalore Institute of Dental Sciences |
| Address |
Department of Periodontology, Bangalore Institute of Dental Sciences, 3rd Floor, Room No. 5, 5/3 Hosur main road adjacent to Nimhans convention center Lakkasandra Wilson Garden Bengaluru Karnataka 560027
Bangalore
KARNATAKA
560027
India |
| Phone |
8220328833 |
| Fax |
|
| Email |
anjujannat10299@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ASMA ANJUM I |
| 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 ASMA ANJUM I |
Bangalore institute of dental sciences |
Department of Periodontology, Bangalore Institute of Dental Sciences, 3rd Floor, Room No. 5, 5/3 Hosur main road adjacent to Nimhans convention center, Lakkasandra, Wilson Garden, Bengaluru Karnataka 560027
Bangalore
KARNATAKA |
08220328833
anjujannat10299@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: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non surgical periodontal therapy (NSPT) scaling and root planing |
full mouth NSPT will be performed in one session lasting not more than one hour supra gingival scaling and sub gingival instrumentation will be done using a combination of ultrasonic and manual instruments |
| Comparator Agent |
Scaling and root planing with Aspirin and Erythropoietin Loaded Hydrogel as local drug delivery |
After completion of scaling and root planing the hydrogel will be injected into the defect site the hydrogel will be injected once every two weeks for two months subgingival application of hydrogel will be delivered through 5ml disposable syringe with blunt needle bent at its shank |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with minimum of 20 teeth excluding 3rd molars should be present patients diagnosed with stage III grade A periodontitis patients with vertical defect measuring greater than or equal to 3mm patient with good general health |
|
| ExclusionCriteria |
| Details |
Individuals with a history of systemic disease such as diabetes mellitus, hypertension, thyroid disorders, etc
Pregnant or lactating women
Patients with a history of regular antiinflammatory medication for past 3 months
Former or current smokers and alcoholics
Patients Allergic to aspirin or erythropoietin
Patients with a history of usage of antibiotics or immunosuppressant medication within 6 months before start of study
Patients with the history of periodontal treatment within the 6 months before the start of study |
|
|
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 Biochemical parameter of assessing the BMP2 levels |
base line
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
gingival index(loe and silness 1963)
plaque index(silness and loe 1964)
probing pocket depth(PPD)
clinical attachment level (CAL) |
baseline
2 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 effect of scaling and root planing (SRP) alone in intra bony defects
To evaluate the effect of scaling and root planing with injectable hydrogels in intra bony defects
To evaluate and compare the clinical radiographic and biochemical parameters before and after treatment between the two groups. |