| CTRI Number |
CTRI/2026/02/104423 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two platelet based treatments for gum disease regeneration |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF RETINOL AUGMENTED INJECTABLE PLATELET RICH FIBRIN AND INJECTABLE PLATELET RICH FIBRIN ALONE IN PERIODONTAL REGENERATION USING MODIFIED MINIMALLY INVASIVE SURGICAL TECHNIQUE A 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 |
Jayalakshmi L |
| Designation |
Post graduate |
| Affiliation |
AJ institute of dental sciences |
| Address |
floor no 1 Room no 3 Dept of periodontics
AJ institute of dental sciences Kuntikan Mangalore 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9380519521 |
| Fax |
|
| Email |
jayalakshmil0409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjushree Kadam |
| Designation |
Professor |
| Affiliation |
AJ institute of dental sciences |
| Address |
floor no 1 Room no 3 Dept of periodontics
AJ institute of dental sciences Kuntikan Mangalore 575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9380519521 |
| Fax |
|
| Email |
manjushreekadam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayalakshmi L |
| Designation |
Post graduate |
| Affiliation |
AJ institute of dental sciences |
| Address |
floor no 1 Room no 3 Dept of periodontics
AJ institute of dental sciences Kuntikan Mangalore 575004
KARNATAKA
575004
India |
| Phone |
9380519521 |
| Fax |
|
| Email |
jayalakshmil0409@gmail.com |
|
|
Source of Monetary or Material Support
|
| A J institute of dental sciences Kuntikana Mangalore India 575004 |
|
|
Primary Sponsor
|
| Name |
Jayalakshmi L |
| Address |
Floor no 1 room no 3 dept of periodontics
A J institute of dental sciences kuntikan Mangalore 575004 |
| 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 Jayalakshmi L |
A J institute of dental sciences |
Floor no 1 Room no 3 Dept of periodontics
Dakshina Kannada
KARNATAKA |
9380519521
jayalakshmil0409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AJIDS ETHICS COMMITTE |
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 |
| Comparator Agent |
Injectable Platelet Rich Fibrin (i-PRF) alone |
Injectable Platelet Rich Fibrin (i-PRF) alone will be prepared using standard low-speed centrifugation protocol. After defect debridement using Modified Minimally Invasive Surgical Technique (M-MIST), i-PRF alone will be injected into the intrabony defect. Flap will be repositioned and sutured. |
| Intervention |
Retinol-augmented Injectable Platelet Rich Fibrin (i-PRF) |
Injectable Platelet Rich Fibrin (i-PRF) prepared according to standard low-speed centrifugation protocol will be augmented with Retinol (Vitamin A) at a standardized concentration. Following flap reflection using Modified Minimally Invasive Surgical Technique (M-MIST), the defect site will be debrided and the Retinol-augmented i-PRF will be injected into the intrabony defect. Flap will be repositioned and sutured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females aged between 18 and 65 years.
2.Subjects with stage-III grade B periodontitis
3. two and three-walled intraosseous defects and probing depth more than or equal to 6mm and clinical attachment loss more than or equal to 4mm
4. intraosseous defect depth more than or equal to 3mm following professional mechanical plaque removal and full-mouth bleeding or plaque score less than or equal to 20 percent |
|
| ExclusionCriteria |
| Details |
1. Subjects with suprabony defects
2. Subjects with I-wall defects.
3. Subjects with grade II/III mobility.
4. Subjects on anticoagulant therapy.
5. Subjects with bleeding disorders.
6. Subjects with smoking habits
7. Pregnancy or breastfeeding at the time of study.
8. Subjects with any systemic illness known to influence the outcome of periodontal surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level (CAL) gain in periodontal intrabony defects |
baseline 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Probing pocket depth (PPD) reduction
Radiographic bone fill
Gingival recession changes
Early wound healing / soft-tissue healing response |
baseline 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2026 |
| 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 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
|
This randomized clinical trial aims to compare the effectiveness of retinol-augmented injectable platelet-rich fibrin (i-PRF) with injectable platelet-rich fibrin (i-PRF) alone when used along with a modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects.
A total of 26 systemically healthy patients with stage III grade B periodontitis will be randomly allocated into two groups. One group will receive retinol-augmented i-PRF with M-MIST, while the control group will receive i-PRF alone with M-MIST. Clinical parameters such as clinical attachment level and probing pocket depth will be evaluated at baseline, 3 months, and 6 months, along with radiographic assessment of bone fill at baseline and 6 months.
The study aims to assess whether the addition of retinol to i-PRF provides any additional benefit in periodontal regeneration compared to i-PRF alone. |