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CTRI Number  CTRI/2025/12/098764 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
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 to find out whether liquid platelet rich fibrin as a carrier medium for local delivery of doxycycline into moderate periodontal pockets has an added advantage to help gums heal better after cleaning in comparison to doxycycline gel alone 
Scientific Title of Study   Comparative evaluation of local drug delivery of doxycycline with a novel vehicle injectable-platelet rich fibrin versus doxycycline gel as an adjunct to nonsurgical periodontal therapy in periodontitis: a randomized controlled 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 Sakshi Aglawe 
Designation  Post Graduate Student 
Affiliation  Yogita Dental College and Hospital 
Address  Room no. 24, Department of Periodontology, Yogita Dental College and Hospital,Naringi Riverside, At Post Tal Dist. SH104, Khed.

Ratnagiri
MAHARASHTRA
415709
India 
Phone  7558542763  
Fax    
Email  aglawesakshi55@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashanth Shetty 
Designation  Professor 
Affiliation  YOGITA DENTAL COLLEGE AND HOSPITAL 
Address  Room no. 24, Department of Periodontology, Yogita Dental College and Hospital,Naringi Riverside, At Post Tal Dist. SH104, Khed.
Room no. 24, Department of Periodontology, Yogita Dental College and Hospital,Naringi Riverside, At Post Tal Dist. SH104, Khed.
Ratnagiri
MAHARASHTRA
415709
India 
Phone  9886191999  
Fax    
Email  mailprs999@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Khushee Agrawal 
Designation  Post Graduate Student 
Affiliation  YOGITA DENTAL COLLEGE AND HOSPITAL 
Address  Room no. 24, Department of Periodontology, Yogita Dental College and Hospital,Naringi Riverside, At Post Tal Dist. SH104, Khed.
Room no. 24, Department of Periodontology, Yogita Dental College and Hospital,Naringi Riverside, At Post Tal Dist. SH104, Khed.
Ratnagiri
MAHARASHTRA
415709
India 
Phone  9833441360  
Fax    
Email  khushee12@gmail.com  
 
Source of Monetary or Material Support  
Room no. 24, Department of Periodontology, Yogita Dental College and Hospital,Naringi Riverside, At Post Tal Dist. SH104, Khed, Maharashtra 415709, India 
 
Primary Sponsor  
Name  Dr Sakshi Aglawe 
Address  Room no. 24, Department of Periodontology, Yogita Dental College and Hospital,Naringi Riverside, At Post Tal Dist. SH104, Khed, Maharashtra 415709, India 
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 Sakshi Aglawe  Yogita Dental College and Hospital  Room number 24, Department of Periodontics and oral implantology, Yogita Dental College and Hospital,Khed
Ratnagiri
MAHARASHTRA 		 07558542763

aglawesakshi55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC- Yogita Dental College and Hospital, Khed  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chronic Periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  doxycycline gel  Local drug delivery of doxycycline gel in moderately deep periodontal pocket at 12 sites 
Intervention  doxycycline with Injectable platelet rich fibrin  Local drug delivery of doxycycline with Injectable Platelet rich fibrin as a vehicle in moderately deep periodontal pockets at 12 sites 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Individuals above 18 years of age.
2. A minimum of 20 natural teeth present
3.Systemically healthy patients diagnosed with periodontitis
4. Patients having pocket probing depth of 4-6 mm.
Diagnosis: Stage II (Grade A, Grade B), Stage III (Grade A, Grade B) According To Classification of Periodontal Diseases 2017)
5. Only patients agreeing to give consent are included.
 
 
ExclusionCriteria 
Details  1.Individuals using any form of alcohol and tobacco.
2.Individuals who have used antibiotics, probiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 3-months.
3.Individuals with systemic diseases.
4.Lactating and/or pregnant females.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pocket Probing Depth
Mild: 0-3mm
moderate: 3-6mm
Severe:more than 6mm 		 Pocket Probing Depth
Mild: 0-3mm
moderate: 3-6mm
Severe:more than 6mm 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Attachment Levels  6 weeks and 12 weeks  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   01/01/2026 
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 - NO
Brief Summary  

AIM- The aim of the study is to evaluate the use of doxycycline with I-PRF as a LDD vehicle

PRIMARY OBJECTIVE:

To evaluate the efficacy of locally delivered doxycycline with I-PRF as a vehicle versus locally delivered doxycycline gel as an adjunct to non-surgical periodontal therapy in periodontitis.

 

SECONDARY OBJECTIVES:

1.To assess the clinical efficacy of doxycycline with IPRF as a local drug delivery vehicle as an adjunct to non-surgical periodontal therapy in periodontitis.

2.To assess the clinical efficacy of doxycycline gel as an adjunct to non -surgical periodontal therapy in periodontitis.

3.To assess and compare the clinical efficacy of locally delivered Doxycycline with IPRF as a vehicle and locally delivered doxycycline gel as an adjunct to non- surgical periodontal therapy in periodontitis

INCLUSION CRITERIA

 1.Individuals above 18 years of age.

2. A minimum of 20 natural teeth present

3.Systemically healthy patients diagnosed with periodontitis

4. Patients having pocket probing depth of 4-6 mm.

Diagnosis: Stage II (Grade A, Grade B), Stage III (Grade A, Grade B)

                   According To Classification of Periodontal Diseases 2017)

5. Only patients agreeing to give consent are included.

 

EXCLUSION CRITERIA

1.Individuals using any form of alcohol and tobacco.

2.Individuals who have used antibiotics, probiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 3-months.

3.Individuals with systemic diseases.

4.Lactating and/or pregnant females.

METHODS OF MEASUREMENT:

Clinical procedure:

1ST Visit

1.Patients satisfying the inclusion criteria will be selected.

2.Thorough scaling and root planing will be done for all patients.

3. Oral hygiene measures instructed to the patients.

2nd Visit

1. Patients will be recalled after 21 days and this visit will be considered as baseline.

2.Clinical parameters will be assessed.

3.Informed consent from the subject will be obtained.

4. At this visit, detailed medical, dental histories as well as periodontal examination will be recorded.

5.Patients will be randomly allotted in Group A and Group B by lottery method.

6. Local drug will be delivered.

3rd visit

1.Patients will be recalled after 6 weeks for follow-up and clinical parameters will be assessed.

4th visit

 1.Patient will be recalled after 12 weeks for follow-up

 2.Patient’s clinical parameters will be assessed.


 
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