| CTRI Number |
CTRI/2025/06/088587 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Assessing the Efficacy of Injectable Platelet Rich Fibrin Delivered Chlorhexidine in Treating Periodontal Pockets |
|
Scientific Title of Study
|
Evaluation Of Injectable Platelet Rich Fibrin As a Novel Vehicle For Local Delivery Of Chlorhexidine In Periodontal Pocket: A Randomized Controlled 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 Alka Snehil |
| Designation |
Post Graduate Student 1st Year |
| Affiliation |
Government Dental College Raipur Chhattisgarh |
| Address |
Room No. 12, Department of Periodontology 3rd floor, Government Dental College Moudhapara Raipur 492001 Chhattisgarh India
Raipur
CHHATTISGARH
492001
India |
| Phone |
6268458262 |
| Fax |
|
| Email |
alkasnehil10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangita Agarwal |
| Designation |
Reader |
| Affiliation |
Government Dental College Raipur Chhattisgarh |
| Address |
Room No. 12, Department of Periodontology 3rd floor Government Dental College Moudhapara Raipur 492001 Chhattisgarh India
Raipur
CHHATTISGARH
492001
India |
| Phone |
7999308410 |
| Fax |
|
| Email |
agsangs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Snehil |
| Designation |
Post Graduate Student 1st Year |
| Affiliation |
Government Dental College Raipur Chhattisgarh |
| Address |
Room No. 12, Department of Periodontology 3rd floor Government Dental College Moudhapara Raipur 492001 Chhattisgarh India
Raipur
CHHATTISGARH
492001
India |
| Phone |
7999308410 |
| Fax |
|
| Email |
alkasnehil10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Dental College Raipur |
| Address |
Government Dental College Raipur 492001 Chhattisgarh India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Alka Snehil |
Government Dental College Raipur |
Room No. 12, Department of Periodontology 3rd floor Government Dental College Moudhapara near marhi mata mandir Raipur 492001 Chhattisgarh India
Raipur
CHHATTISGARH |
06268458262
alkasnehil10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Dental College Raipur |
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 |
Injectable Platelet Rich Fibrin |
use of injectable platelet rich fibrin as a local drug delivery in four different groups comparing the efficacy of drug chlorhexidine along with injectable platelet rich fibrin |
| Comparator Agent |
Scaling and root planing and Xanthan based chlorhexidine |
comparision will be done on the basis of addition of chlorhexidine in injectable platelet rich fibrin with patients undergoing scaling and root planing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
participants will be chosen on the basis of systemically healthy individual diagnosed with periodontitis stage II grade B with probing depth of more than 5 mm in at least two sites |
|
| ExclusionCriteria |
| Details |
Patients with hemogolobin level less than 11 mg/dL and having habit of smoking and pregnant women or patients under any antibiotic or anti inflammatory therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
: Injectable platelet rich fibrin (iPRF) as a vehicle for delivery
of chlorhexidine will cause effective release of drug in periodontal pocket with
improvement in clinical and microbial parameters at follow up. |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Injectable platelet rich fibrin (iPRF) based local
chlorhexidine delivery will have better or comparable effectiveness when
compared to commercially available chlorhexidine gel for delivery in periodontal
pocket. |
15 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/06/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The study is designed to measure the efficacy of Injectable platelet rich fibrin as a local delrug delivery of drug chlorhexidine in the periodontal pocket the different groups have been allocated to determine the comparison and effectiveness of injectable platelet rich fibrin as a local drug delivery system as it is autologous in nature . Four Different groups include use of scaling and root planing and Injectable platelet rich fibrin and chlorhexidine.other group includes the use of scaling and root planing and xanthan based chlorhexidine. other group includes the use of scaling and root planing and injectable platelet rich fibrin and the last group includes patirnts with scaling and root planing only.The study will evaluate the effectiveness of injectable platelet rich fibrin as a vehicle for delivery of chlorhexidine will cause effective release of drug in periodontal pocket with improvement in clinical and microbial parameters at follow up. |