| CTRI Number |
CTRI/2025/05/087678 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing injectable Hyaluronic Acid and injectable Platelet Rich Fibrin as gum therapy agent along with cleaning in patients with gum diseases. |
|
Scientific Title of Study
|
Comparative evaluation of injectable Hyaluronic Acid (HA) versus injectable Platelet Rich Fibrin (I-PRF) as a pocket therapy along with scaling and root planing in patients with 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 |
Dr Aparna Ashwarya |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Room number 4
Department of Periodontics
Coorg Institute of dental sciences
K.K. campus Maggula village
Virajpet Coorg district
Karnataka
Kodagu
KARNATAKA
571218
India |
| Phone |
8660527185 |
| Fax |
|
| Email |
aparnaashwarya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Ashwarya |
| Designation |
Post graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Room number 4
Department of Periodontics
Coorg Institute of dental sciences
K.K. campus Maggula village
Virajpet Coorg district
Karnataka
Kodagu
KARNATAKA
571218
India |
| Phone |
8660527185 |
| Fax |
|
| Email |
aparnaashwarya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Amit K Walvekar |
| Designation |
Head of Department |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Room number 4
Department of Periodontics
Coorg Institute of dental sciences
K.K. campus Maggula village
Virajpet Coorg district
Karnataka
Kodagu
KARNATAKA
571218
India |
| Phone |
9480085687 |
| Fax |
|
| Email |
amitakw@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Room number 4
Department of Periodontics
Coorg Institute of dental sciences
K.K. campus Maggula village
Virajpet Coorg district
Karnataka India
pin code 571218 |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Ashwarya |
| Address |
Room number 4
Department of Periodontics
Coorg Institute of dental sciences
K.K. campus Maggula village
Virajpet Coorg district
Karnataka india 571218 |
| 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 Aparna Ashwarya |
Coorg Institute of dental sciences |
Room number 4
Department of Periodontics
K.K. campus Maggula village
Virajpet Coorg district
Karnataka
Kodagu
KARNATAKA |
8660527185
aparnaashwarya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, Coorg institute of dental science |
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 Hyaluronic Acid |
Injectable Hyaluronic acid will be applied subgingivally till the pocket is filled and overflow following scaling and root planing at baseline and reviewed after 1 and 3 months. |
| Intervention |
Injectable Platelet Rich Fibrin |
Injectable Platelet Rich Fibrin will be placed at the base of pocket at point of interdental space following scaling and root planing at baseline and reviewed after 1 and 3 months. |
| Comparator Agent |
Scaling and root planing |
After sample collection scaling and root planing to be done at baseline following initial examination and reviewed after 1 and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with stage 2 periodontitis (grade A) and willing for treatment.
Patients with periodontal pocket depth of less than or equal to 5mm in atleast 3 quadreants.
Minimum of 15 teeth should be remaining.
Patient of 25 to 55 years of age. |
|
| ExclusionCriteria |
| Details |
Systemically compromised patients.
Use of antibiotics in the past 6 months
Steroid or inflammatory drugs for 7 days in 3 months
Known allergy to the above mentioned drugs/substance
Smokers and alcoholic
Pregnant and lactating women
Periodontal therapy within 6 months
Bleeding and clotting disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical efficacy of Injectable Hyaluronic Acid and Injectable Platelet Rich Fibrin as an adjuct to scaling and root planing on clinical parameters in patients with stage 2 periodontitis. |
All clinical parameters will be measured at baseline, 1 month and 3 months and Injectable Hyaluronic Acid and Injectable Platelet Rich Fibrin will be injected at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical efficacy of Injectable Hyaluronic Acid & Injectable Platelet Rich Fibrin as an ajunct to scaling root planing & scaling root planing alone on clinical parameters in patients with stage 2 periodontitis. |
All clinical prameters will be measured at baseline, 1 month & 3 months & Injectable Hyaluronic Acid & Injectable Platelet Rich Fibrin will be injected at baseline. |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| Date of Study Completion (India) |
15/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
AIM To compare the results of clinical parameters between scaling and root planing alone group, injectable hyaluronic acid group and injetable platelet rich fibrin as an adjunct to scaling and root planing.
METHODOLOGY This is a split mouth
study design where 25 patients of both gender with stage 2 periodontitis (grade
A) satisfying all the inclusion criteria will be enrolled for the study. For
each patient 3 quadrants will be chosen and randomly allocated using
computerized randomization method into three groups. Areas with deepest probing
depths will be included for application of injectable hyaluronic acid and
injectable platelet rich fibrin and is treated by scaling and root.
|