| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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. |