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CTRI Number  CTRI/2026/01/100249 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Seeing the additive effect of a growth factor derived from blood, and one percent metformin gel, a medicine used for treating diabetes, for treating infection in jaw bone due to a disease known as periodontitis. 
Scientific Title of Study   Clinico-radiographic evaluation of one percent metformin gel and leucocyte-platelet rich fibrin in patients with periodontal intrabony defects a randomised clinical study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mitali Parikh 
Designation  Junior resident 
Affiliation  Faculty of Dental Sciences, King George Medical University 
Address  Room no. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh
Room no. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9795708866  
Fax    
Email  mitaliparikh0104@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Professor Dr Nand Lal 
Designation  Head of Department 
Affiliation  Faculty of Dental Sciences, King George Medical University 
Address  Room no. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415085653  
Fax    
Email  nandlal@kgmcindia.edu.in  
 
Details of Contact Person
Public Query
 
Name  Professor Dr Nand Lal 
Designation  Head of Department 
Affiliation  Faculty of Dental Sciences, King George Medical University 
Address  Room no. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415085653  
Fax    
Email  nandlal@kgmcindia.edu.in  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Self 
Address  Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 
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 
Mitali Parikh  Faculty of Dental Sciences, King Georges Medical University  Post Graduate Clinic, Room no. 14, Department of Periodontology, 5th Floor, New Dental Building, CP Govilla Block, Faculty of Dental Sciences, King Georges Medical University, Shah Mina, Chowk
Lucknow
UTTAR PRADESH 
9795708866

mitaliparikh0104@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University U.P., Institutional Ethics Committee, Lucknow- 226003  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 1- Debridment of the bone defect  The first study group will consist only the debridment of bone defect caused due to periodontitis 
Intervention  Group 2- Debridment of bone defect combined with leucocyte platelet rich fibrin.  The second study group consists of debridment and addition of leucocyte platelet rich fibrin to bone defect caused due to periodontitis. 
Intervention  Group 3- Debridment of bone defect combined with one percent metformin gel.  The third study group consists of debridment and addition of one percent metformin gel to bone defect caused due to periodontitis. 
Intervention  Group 4- Debridment of bone defect combined with leucocyte platelet rich fibrin and one percent metformin gel together  The fourth study group consists of debridment and addition of leucocyte platelet rich fibrin and one percent metformin gel together to bone defect caused due to periodontitis.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients should be able to maintain proper oral hygiene. Patients with chronic periodontitis with intrabony periodontal defects Patients should be free from any chronic systemic disease. Patients who have signed the consent form.
 
 
ExclusionCriteria 
Details  Patients suffering from any other condition affecting periodontal health i.e. aggressive periodontitis, etc. Pregnant women and lactating mothers. Patients suffering from any chronic systemic diseases. Patients under medication which is known to affect prognosis of periodontal diseases. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy of one percent Metformin and leucocyte platelet rich fibrin in treatment of intrabony periodontal defects.  outcome will be assessed on baseline that is on the day of surgery, 3 months, and 6 months . 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   10/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/01/2026 
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  
Introduction
Periodontal disease causes long lasting inflammation in the tissues surrounding the teeth which leads to loss of attachment and bone destruction. Intrabony periodontal defects are common findings and require regenerative treatment for predictable healing. Platelet rich fibrin is an autologous fibrin matrix that provides growth factors which support wound healing and bone regeneration. Metformin is an antidiabetic drug that has also shown beneficial effects on osteoblast activity and bone formation. Both materials have been studied separately but there is limited evidence on their combined use.

This randomized clinical study aims to evaluate and compare the effectiveness of one percent metformin gel and leucocyte rich platelet rich fibrin in the treatment of intrabony periodontal defects. Patients will be divided into four groups. group one will receive surgical debridement alone. group two will receive surgical debridement with leucocyte rich platelet rich fibrin. group three will receive surgical debridement with one percent metformin gel. group four will receive surgical debridement in combination with leucocyte rich platelet rich fibrin and one percent metformin gel. Clinical parameters including plaque index gingival index pocket depth and vertical clinical attachment loss along with radiographic assessment will be recorded at baseline three months and six months. This study will help to determine whether the combined use of leucocyte rich platelet rich fibrin and metformin offers additional benefits for periodontal regeneration.

Primary Outcome
Change in intrabony defect depth measured clinically and radiographically at baseline three months and six months.

Change in pocket depth at baseline three months and six months.
Change in vertical clinical attachment level at baseline three months and six months.
Change in plaque index and gingival index at baseline three months and six months.
Comparison of healing response among all four treatment groups.

Intervention Details

Group One Surgical Debridement Alone
Removal of granulation tissue scaling and root planing and flap closure.

Group Two Surgical Debridement with Leucocyte Rich Platelet Rich Fibrin
Surgical debridement followed by placement of leucocyte rich platelet rich fibrin prepared from patient blood. Flap closure is done.

Group Three Surgical Debridement with One Percent Metformin Gel
Surgical debridement followed by placement of one percent metformin gel into the defect area. Flap closure is done.

Group Four Surgical Debridement with Leucocyte Rich Platelet Rich Fibrin and One Percent Metformin Gel
Surgical debridement followed by placement of leucocyte rich platelet rich fibrin and one percent metformin gel combined in the defect. Flap closure is done.
 
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