| CTRI Number |
CTRI/2026/03/105576 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to check whether metformin gel with a healing material made from ones own blood improves gum and bone healing in lower back teeth having bone loss between roots of teeth. |
|
Scientific Title of Study
|
Clinico-radiographic assessment of 1 percent metformin gel with Advanced-platelet-rich fibrin in the treatment of mandibular grade 2 furcation defects - A Split-Mouth Clinical 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 Isha Jaju |
| Designation |
MDS PG student |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Pravara Institute of Medical Sciences, Rural Dental College, Department of Periodontology, room no 404, Loni, Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7218403956 |
| Fax |
|
| Email |
ishajaju178@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raju Anarthe |
| Designation |
Professor and Guide |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Pravara Institute of Medical Sciences, Rural Dental College, Department of Periodontology, room no 404, Loni, Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9860925006 |
| Fax |
|
| Email |
rajuanarthe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raju Anarthe |
| Designation |
Professor and Guide |
| Affiliation |
Pravara Institute of Medical Sciences |
| Address |
Pravara Institute of Medical Sciences, Rural Dental College, Department of Periodontology, room no 404, Loni, Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9860925006 |
| Fax |
|
| Email |
rajuanarthe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pravara Institute of Medical Sciences, College of Pharmaceutical Sciences, Loni, Ahmadnagar, 413736 |
| Pravara Institute of Medical Sciences, Rural Dental College, Loni, Ahmadnagar, 413736 |
|
|
Primary Sponsor
|
| Name |
Pravara Institute of Medical Sciences |
| Address |
Pravara Institute of Medical Sciences, Rural Dental College, Department of Periodontology, room no. 404, Loni, Ahmadnagar, Maharashtra 413736 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Isha Jaju |
Rural Dental College |
Pravara Institute of Medical Sciences,Department of Periodontology,room no 404,Rural Dental College,Loni 413736
Ahmadnagar
MAHARASHTRA |
7218403956
ishajaju178@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PIMS DU LONI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 percent Metformin gel in combination with Advanced platelet rich fibrin |
Metformin has osteogenic, anti-inflammatory, and immunomodulatory properties and A-PRF has more porous fibrin network and increased cellular entrapment which enhances growth factor release and their regenrative propertities will be evaluated at an interval of 3 months { 3 months ,6 months and 9 months} |
| Comparator Agent |
Advanced Platelet rich fibrin (A-PRF) |
A-PRF has more porous fibrin network and increased cellular entrapment which enhances growth factor release which is used as bone regeneration material and will be evaluated at interval of 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patiets willing and able to provide informed consent.
2.Medically healthy patients with no systemic diseases.
3.Diagnosed with chronic periodontitis.
4.Patients capable of maintaining good oral hygiene.
5.Asymptomatic mandibular first and second molars exhibiting radiolucency in the furcation area on intraoral periapical radiographs (IOPA) bilaterally.
6.Presence of bilateral Grade 2 furcation defects in mandibular molars that are endodontically vital (as confirmed clinically and radiographically).
7.Patients with a minimum of 20 permanent teeth, including at least two teeth with Grade 2 furcation defects, horizontal probing depth (PD) more than 3 mm, interproximal Probing depth more than or equal to 5 mm, and clinical attachment loss more than or equal to 3 mm, evaluated 8 weeks after Phase I therapy (scaling and root planing).
|
|
| ExclusionCriteria |
| Details |
1.Hematological disorders or immunocompromised status.
2.Pregnant or lactating women.
3.Smokers or users of any form of tobacco.
4.Use of medications known to interfere with wound healing or bone metabolism.
5.History of systemic antibiotic therapy or periodontal treatment within the past 6 months.
6.Restorations extending beyond the cemento-enamel junction (CEJ) at the defect site.
7.Indistinguishable CEJ, either clinically or radiographically.
8.Presence of periapical pathology, unrestored caries, defective restorations, root resorption, or vertical root fracture.
9.Tooth mobility classified as Miller Class 2 or greater.
10.Unacceptable oral hygiene (Plaque Index more than 1.5) after re-evaluation of Phase I therapy.
11.Patients unwilling to provide informed consent.
12.Known allergy to metformin or history of its systemic use.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of 1 percent metformin gel and A-PRF under parameters of radiographic assessment of bone gain in furcation area and defect fill |
Every 3 months for 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of 1 percent metformin gel and A-PRF under parameters like probing pocket depth, clinical attachment level, plaque index. |
Every 3 months for 9 months |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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 3 |
|
Date of First Enrollment (India)
|
13/03/2026 |
| 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="2"
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
|
This split-mouth randomized controlled clinical trial aims to evaluate the clinical and radiographic effectiveness of 1 percent metformin gel used adjunctively with advanced platelet-rich fibrin (A-PRF) compared with A-PRF alone in the treatment of bilateral Grade 2 furcation defects. Twenty-one systemically healthy patients aged 30–55 years with chronic periodontitis and bilateral mandibular molar Grade 2 furcation involvement will be recruited following Phase I therapy. Test sites will receive open flap debridement (OFD) with 1 percent metformin gel and A-PRF, while control sites will be treated with OFD and A-PRF alone. Clinical parameters including probing pocket depth, clinical attachment level, plaque index, and furcation defect, along with radiographic bone fill, will be assessed at baseline, 3, 6, and 9 months using standardized stents and radiographic techniques. The primary outcome will be furcation defect reduction and radiographic bone fill, while secondary outcomes will include PPD reduction, CAL gain, and plaque index improvement, to determine whether adjunctive metformin provides superior regenerative benefits in Grade 2 furcation therapy. |