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CTRI Number  CTRI/2026/01/101111 [Registered on: 14/01/2026] Trial Registered Prospectively
Last Modified On: 14/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing gum healing using a patient’s own blood clot, with and without an antibiotic. 
Scientific Title of Study   Clinico-Microbiological Evaluation of Doxycyline Infused Titanium-Platelet Rich Fibrin in Surgical Management of Periodontal Pockets Compared to Titanium-Platelet Rich Fibrin Alone: 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  Dr Nikita Jitendra Khode 
Designation  Post Graduate Student 
Affiliation  SMBT Dental College and Hospital, Sangamner 
Address  G-02 Department of Periodontology and Oral Implantology, SMBT Dental College and Hospital, Sangamner, Ahmadnagar, Maharashtra 422608

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9657120277  
Fax    
Email  nikitakhode1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lisa Chacko 
Designation  Professor and PG Guide 
Affiliation  SMBT Dental College and Hospital, Sangamner 
Address  G-02 Department of Periodontology and Oral Implantology, SMBT Dental College and Hospital, Sangamner, Ahmadnagar, Maharashtra 422608

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  7378488875  
Fax    
Email  lisabrahamj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikita Jitendra Khode 
Designation  Post Graduate Student 
Affiliation  SMBT Dental College and Hospital, Sangamner 
Address  G-02 Department of Periodontology and Oral Implantology, SMBT Dental College and Hospital, Sangamner, Ahmadnagar, Maharashtra 422608

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9657120277  
Fax    
Email  nikitakhode1999@gmail.com  
 
Source of Monetary or Material Support  
SMBT Dental College and Hospital, Sangamner, Maharashtra 422608 
 
Primary Sponsor  
Name  Dr. Nikita Jitendra Khode 
Address  G-02 Department of Periodontology and Oral Implantology, SMBT Dental College and Hospital, Sangamner, Ahmadnagar, Maharashtra 422608 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikita Jitendra Khode  SMBT Dental College and Hospital  G-02 Department of Periodontology and Oral Implantology SMBT Dental College and Hospital Sangamner Ahmadnagar Maharashtra 422608
Ahmadnagar
MAHARASHTRA 		 9657120277

nikitakhode1999@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Doxycyline Infused Titanium-Platelet Rich Fibrin  Sites will be treated using Open Flap Debridement (OFD) and Doxycyline infused Titanium Platelet Rich Fibrin (OFD + Doxycyline infused T-PRF) 
Comparator Agent  Titanium-Platelet Rich Fibrin Alone  Sites will be treated using open flap debridement (OFD) and Titanium Platelet Rich Fibrin (OFD + T-PRF) 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of both sexes between 30 and 65 years of age with moderate to severe generalized periodontitis.
2. Patients exhibiting atleast two periodontal pockets with a probing pocket depth of more than or equal to 5mm and clinical attachment loss (CAL) of more than or equal to 4mm in any two quadrants.
3.No history of intake of antibiotics or other medications affecting the periodontium in preceding 6 months.
4.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 or anti platelet or anti coagulant therapy. 
 
Method of Generating Random Sequence   Computer generated randomization 
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)
5.Microbiological analysis to quantify the colony forming units of Porphyromonas gingivalis. 		 Baseline, 3 months and 6 months after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   29/01/2026 
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="1"
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nikitakhode1999@gmail.com].

  6. For how long will this data be available start date provided 15-05-2026 and end date provided 15-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized, single blinded split mouth clinical trial aims to evaluate and compare the clinical and microbiological efficacy of Doxycycline infused Titanium Platelet Rich Fibrin (TPRF) versus TPRF alone when used as an adjunct to open flap debridement (OFD) in the management of deep periodontal pockets. Twenty patients presenting with periodontal pockets measuring more than or equal to 5mm will be enrolled, contributing a total of 40 sites. Following Phase I periodontal therapy and re evaluation, sites will be randomly allocated into test and control groups. Test sites will receive OFD with doxycycline infused TPRF, while control sites will receive OFD with TPRF alone. TPRF will be prepared from autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol. Clinical parameters including plaque index, gingival index, probing pocket depth, and relative clinical attachment level will be recorded at baseline, 3 months, and 6 months postoperatively. Microbiological evaluation of Porphyromonas gingivalis colony forming units will be performed at baseline and 3 months. The study aims to determine whether doxycycline infused TPRF provides superior clinical and antimicrobial outcomes compared to TPRF alone in periodontal pocket therapy. 
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