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CTRI Number  CTRI/2025/04/083963 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TREATMENT OF PERIODONTAL Intra bony defects by using TPRF and 1% METFORMIN gel.  
Scientific Title of Study   A comparative evaluation of TITANIUM PLATELET RICH FIBRIN alone and in combination with 1% METFORMIN GEL in the treatment of intra bony defects; 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 MANIKANTA JAJAM 
Designation  POST GRADUATE STUDENT  
Affiliation  DR. N.T.R UNIVERSITY OF HEALTH SCIENCES 
Address  DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE
7 27 23 VIJAYA TALKIES ROAD GHANDI BAZAR MARKAPUR 523316
Srikakulam
ANDHRA PRADESH
532001
India 
Phone  8886712823  
Fax    
Email  jajammani22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K. ANIL KUMAR 
Designation  PROFESSER AND HEAD OF THE DEPARTMENT  
Affiliation  DR. N.T.R UNIVERSITY OF HEALTH SCIENCES 
Address  DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE CHAPURAM
SREE SAI DENTAL COLLEGE AND REASEARCH INSTITUTE
Srikakulam
ANDHRA PRADESH
532001
India 
Phone  9989570600  
Fax    
Email  anilkanc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MANI KANTA JAJAM 
Designation  POSTGRADUATE STUDENT  
Affiliation  DR. N.T.R UNIVERSITY OF HEALTH SCIENCES 
Address  DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE CHAPURAM
7 27 23 VIJAYA TALKIES ROAD GHANDI BAZAR MARKAPUR 523316
Srikakulam
ANDHRA PRADESH
532001
India 
Phone  8886712823  
Fax    
Email  jajammani22@gmail.com  
 
Source of Monetary or Material Support  
DOOR NUMBER 6 2 15 Chapuram National highway Palasa to Srikakulam Peda Padu Road Srikakulam 532001  
 
Primary Sponsor  
Name  Dr J MANIKANTA 
Address  SECOND YEAR POST GRADUATE DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTION SRIKAKULAM 532401 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr J Manikanta   sree sai dental college   Room no-8 D.No: 6-2-15 , Chinnabazar , Chapuram, Srikakulam Srikakulam Dist. Pincode: 532 001
Srikakulam
ANDHRA PRADESH 
08886712823

jajammani22@gmail.com 
Dr J Manikanta  sree sai dental college   Room no - 8, D.No: 6-2-15 , Chinnabazar , Chapuram, Srikakulam Srikakulam Dist. Pincode: 532 001
Srikakulam
ANDHRA PRADESH 
08886712823

jajammani22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  open flap debridement and metformin gel   The patient is treated with open flap debridement 1 percent metformin gel as a control a 6 month study 
Intervention  T-prf + metformin gel  patient is treated with open flap debridement 1 percent metformin gel along with Titanium prf a 6 month study 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details 
Inclusion criteria

1) Age 25 to 55 years

2) systematically healthy Patients with periodontitis​

3) ​ Presence of Intra bony defect greater than 3mm

4) Minimum of 2 teeth with probing pocket depth greater than 5 mm on either side of the same arch

5) Clinical attachment loss greater than 4mm ​

6) Depiction of angular defects in the intraoral periapical radiograph​



 
 
ExclusionCriteria 
Details 
Exclusion criteria

1) Patients with aggressive periodontitis​

2) systemic diseases​

3) patients who had no active periodontal therapy and drug history in the past 6 months

4) Smokers​

5) Pregnant and lactating women were excluded from the study

6) Mobile nonvital ​poor prognosed teeth

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
primary outcome : decreased pocket depth, reduced CAL , bone fill
secondary outcome: plaque index, gingival index, bleeding index 
baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
plaque index, gingival index, bleeding index.  base line and 6 months 
decreased pocket depth, reduced CAL , bone fill  baseline to 6 months 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   28/07/2025 
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="7"
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  

  The split mouth study will consist of 12  systemically healthy patients visiting the Department of Periodontics. An informed consent will be obtained from the patients. Initially scaling and root planning will be done under local anesthesia followed by oral hygiene instruction. The patient will be recalled for periodontal surgery. The following clinical and radiographic parameters will be recorded at baseline, 6 months Stent fabrication Two acrylic stents for each site were prepared and checked for proper stability one for CAL and the other for measuring the depth of interproximal bony defects during the surgical procedures  PRF-T rpm Just before the surgery, intravenous blood was collected in a 10 ml sterile titanium test tube without anticoagulant by vein puncturing of the antecubital vein The tubes were immediately centrifuged at 3000 rpm for 10 minutes in a centrifuge machine (C-852, REMI, Mumbai, INDIA). Blood centrifugation immediately after collection allows the composition of a structured fibrin clot in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma (Platelet Poor Plasma (PPP)) at the top TPRF clot thus formed was separated using sterile tweezers and scissors and transferred onto PRF box and a stable fibrin membrane was obtained by squeezing serum out of the T-PRF clot 1%Metformin gel are formulated from perioBiologics LLP laboratory Hydereabad.

 
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