| CTRI Number |
CTRI/2026/02/103924 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Checking if mixing an antibiotic (metronidazole) into a special healing material made from the patient’s own blood (T-PRF) helps gum surgery work better than using the healing material by itself. |
|
Scientific Title of Study
|
Evaluating the efficacy of metronidazole-loaded TPRF in open flap debridement for periodontitis management: a randomized controlled 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 Sakshi Vidhale |
| Designation |
Post-graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7775009640 |
| Fax |
|
| Email |
drsakshividhale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lisa Chacko |
| Designation |
Professor and PG Guide |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7378488875 |
| Fax |
|
| Email |
lisabrahamj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Vidhale |
| Designation |
Post-graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7775009640 |
| Fax |
|
| Email |
drsakshividhale@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital,Amrutnagar-Ghulewadi Sangamner,
Ahmednagar, Maharashtra, India 422608 |
|
|
Primary Sponsor
|
| Name |
Dr. Sakshi Vidhale |
| Address |
G-02, Department of Periodontology, SMBT Dental College and
Hospital, Amrutnagar-Ghulewadi, Sangamner, Ahmednagar,
Maharashtra 422608 |
| 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 Sakshi Vidhale |
SMBT Dental College and Hospital |
G-02, Department of
Periodontology,
Sangamner
Ahmadnagar
MAHARASHTRA |
7775009640
drsakshividhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental College, Sangamner |
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 |
Metronidazole-loaded Titanium
prepared platelet-rich fibrin |
After intraoral (0.2% chlorhexidine) and extraoral (iodine) antisepsis, local anesthesia (2% lignocaine with adrenaline 1:200,000) will be administered. A full-thickness mucoperiosteal flap will be raised using intrasulcular incisions, followed by thorough periodontal debridement. 10 mL of intravenous blood will be collected in sterile titanium tubes without anticoagulant. Two milliliters of metronidazole (3 mg/mL) will be added prior to centrifugation at 2700 rpm for 12 minutes to obtain metronidazole-loaded T-PRF which will be placed in the defect, and the flaps will be repositioned and sutured. |
| Comparator Agent |
Titanium prepared platelet-rich fibrin |
After intraoral (0.2% chlorhexidine) and extraoral (iodine) antisepsis, local anesthesia (2% lignocaine with adrenaline 1:200,000) will be administered. A full-thickness mucoperiosteal flap will be raised using intrasulcular incisions, followed by thorough periodontal debridement. 10 mL of intravenous blood will be collected in sterile titanium tubes without anticoagulant and centrifuged at 2700 rpm for 12 minutes to obtain T-PRF which will be placed in the defect, and the flaps will be repositioned and sutured |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients exhibiting atleast two periodontal pockets with a probing pocket depth of or more than 5mm and clinical attachment loss (CAL) of or more than 4mm in any two quadrants.
2. No history of intake of antibiotics or other medications affecting the periodontium in preceding 6 months.
3. Patient willing for surgery and ready to give written consent.
|
|
| ExclusionCriteria |
| Details |
1. Systemic illness or diagnosis of heart condition that would require prophylactic antibiotic cover.
2. Smokers, pregnant or lactating patients will be excluded.
3. Patient with any known allergy to any kind of medication.
4. Platelet count less than 1.5 platelets per microliter.
5. Patient with bleeding disorder, anti platelet or anti coagulant therapy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Plaque index
2.Gingival index
3.Site specific Probing pocket depth (PPD)
4.Relative clinical attachment level (RCAL) |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="9"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsakshividhale@gmail.com].
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-05-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The aim of this randomized clinical trial is to compare the clinical efficacy of metronidazole-loaded Titanium-Prepared Platelet-Rich Fibrin (T-PRF) and T-PRF alone as adjuncts to open flap debridement (OFD) in the surgical management of periodontal pockets. After obtaining informed consent and recording a comprehensive case history, 30 patients with moderate to severe generalized periodontitis will be enrolled and randomly allocated into two groups: a test group treated with OFD + metronidazole-loaded T-PRF and a control group treated with OFD + T-PRF alone. Following phase I periodontal therapy, patients will be clinically re-evaluated to confirm suitability for surgery. Randomization will be performed using computer-generated tables, and outcome assessment will be single-blinded to minimize bias.
All surgical procedures will be performed by a single operator using a standardized OFD protocol. Metronidazole-infused T-PRF and T-PRF membranes will be prepared from autologous blood using titanium tubes and placed into the periodontal defects following thorough debridement. Clinical parameters including Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), and Relative Clinical Attachment Level (RCAL) will be recorded at baseline, 3 months, and 6 months postoperatively to evaluate treatment outcomes. |