| CTRI Number |
CTRI/2026/04/107386 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Titanium- Platelet rich fibrin] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares two treatments used with deep cleaning for gum disease—one using a natural healing material from the patient’s blood, and the other with added medicine—to see which works better. |
|
Scientific Title of Study
|
Comparative evaluation of the clinical efficacy of titanium - platelet rich fibrin (t-prf) and titanium – platelet rich fibrin loaded with doxycycline as an adjunct to non-surgical periodontal therapy in stage ii periodontitis patients - a split mouth study |
| 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 Apoorva Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room number 4
Department Of Periodontics And Implantology
Coorg Institute of Dental Sciences SH 88B Kodagu Virajpet Aimangala Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
6363450697 |
| Fax |
|
| Email |
guptaapoorva85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apoorva Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room number 4
Department Of Periodontics And Implantology
Coorg Institute of Dental Sciences SH 88B Kodagu Virajpet Aimangala Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
6363450697 |
| Fax |
|
| Email |
guptaapoorva85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayaprakash G S |
| Designation |
Professor |
| Affiliation |
Coorg Institute Of Dental Sciences |
| Address |
Room number 4
Department Of Periodontics And Implantology
Coorg Institute of Dental Sciences SH 88B Kodagu Virajpet Aimangala Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9972912662 |
| Fax |
|
| Email |
jayaprakashgadagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences, Department Of Periodontics And Implantology, Room Number 4 SH 88B, Kodagu, Virajpet, Aimangala, Karnataka 571218 |
|
|
Primary Sponsor
|
| Name |
Dr Apoorva Gupta |
| Address |
Coorg Institute of Dental Sciences, SH 88B, Kodagu, Virajpet, Aimangala
Karnataka 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 Apoorva Gupta |
Coorg Institute of Dental Sciences |
Department of Periodontology and Implantology, room number 4, SH 88B, Kodagu, Virajpet, Aimangala, Karnataka 571218
Kodagu
KARNATAKA |
6363450697
guptaapoorva85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients diagnosed with Stage II periodontitis will be divided into three groups in which, Group 1 will receive scaling and root planing alone, Group 2 will receive scaling and root planing combined with titanium-prepared platelet-rich fibrin, and Group 3 will receive scaling and root planing combined with doxycycline-loaded titanium-prepared platelet-rich fibrin. |
Patients diagnosed with Stage II periodontitis will be divided into three groups in which, Group 1 will receive scaling and root planing alone, Group 2 will receive scaling and root planing combined with titanium-prepared platelet-rich fibrin, and Group 3 will receive scaling and root planing combined with doxycycline-loaded titanium-prepared platelet-rich fibrin.Plaque index, Gingival Index, Probing depth, Clinical Attachment Level and Bleeding on probing will be measured at baseline,1 month and 3 months to assess the effect of the treatment. |
| Intervention |
Patients diagnosed with Stage II periodontitis will be divided into three groups in which, Group 1 will receive scaling and root planing alone, Group 2 will receive scaling and root planing combined with titanium-prepared platelet-rich fibrin, and Group 3 will receive scaling and root planing combined with doxycycline-loaded titanium-prepared platelet-rich fibrin. |
The procedure will be performed only once, immediately after scaling and root planing in all patients. Group 1 will recieve scaling and root planing alone. For Group 2, 10 mL of blood will be drawn and transferred to titanium tubes, followed by centrifugation at 2700 rpm for 12 minutes to obtain T-PRF; the clot will be separated, compressed into a membrane, and placed subgingivally into periodontal pockets using a plastic filling instrument, followed by Coe-pack application. For Group 3, the same procedure will be followed, except that doxycycline (2 mL, 3 mg/mL) will be added to the tube prior to centrifugation to prepare T-PRF loaded with doxycycline, which will then be placed subgingivally in a similar manner and covered with Coe-pack. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of age between 25 and 55 years
2)Patients with stage II Periodontitis with probing pockets depth of more than or equal to 5 mm in at least 3 quadrants.
3)Patients with no history of periodontal therapy in the past six months.
|
|
| ExclusionCriteria |
| Details |
1)Current smokers and alcoholics.
2)History of antimicrobial therapy in the past 6 months
3)Patients with any other systemic diseases.
4)Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the clinical efficacy of Titanium- platelet-rich fibrin and Titanium- platelet-rich fibrin loaded with doxycycline as an adjunct to scaling and root planing in stage II periodontitis patients. |
Clinical measurements will be recorded at baseline, 1 month, and 3 months during the follow-up period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
30/04/2026 |
| 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="0"
Months="3"
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 split mouth study will assess the clinical efficacy of titanium platelet rich fibrin and titanium platelet rich fibrin loaded with doxycycline as an adjunct to non surgical therapy in stage II periodontitis patients. A total of 33 patients diagnosed with Stage II periodontitis will be selected based on predefined inclusion and exclusion criteria. All participants will undergo non surgical periodontal therapy consisting of scaling and root planing. In Group A, patients will undergo scaling and root planing alone, in group B patients will undergo scaling and root planing with titanium platelet rich fibrin as an adjunct and in Group C, patients will undergo scaling and root planing with titanium platelet rich fibrin and doxycycline as an adjunct. Clinical measurements including plaque index , gingival Index , probing depth, clinical attachment level and bleeding on probing will be recorded at baseline, 1 month, and 3 months during the follow-up period. |