Clinical Efficacy of 1% Metformin and Alendronate Gel in Adjunct to Fibrin in Chronic Periodontitis

Summary

This open label, randomized controlled clinical trial study will be conducted after obtaining ERC approval of Bahria University Health Sciences. Written informed consent will be taken from all study participants. Patients suffering from moderate to severe chronic periodontitis and diagnosed as per criteria Community Periodontal Index for Treatment Needs (CPITN) (Heiko Z et al, 2015) will be selected from the Oral Diagnostic \& Periodontology department of Islamabad Medical \& Dental College hospital . Patients will be randomized into 3 groups by using computer driven list. Sample size will be calculated by using software G power version3.1.9.2 . Patients will be randomly divided into 3 groups.

(I) Baseline investigations/parameters (at day zero): FBS values will be monitored using digital glucometer Clinical parameters (PI, CAL, PDD, mSBI) will be assessed at baseline, 3 , 6 , 9 \& 12 months by calibrated periodontal probe. Radiological parameters (VBL \& IBDA) will be carried out using OPG at baseline, 6 \& 12 months. ELISA for Transforming growth factor (TGFβ) and osteocalcin biomarkers will be done at baseline and 3 months. RT-PCR for the detection of RUNX2 gene will be done at baseline and 3 months Patient will be called at 14th day for suture removal and clinical assessment . Follow up will be done at 3, 6, 9 and 12 months to assess clinically. Radiographic parameters will be assessed at 6 \&12 months. Pharmacogenetic parameters will be assessed at 6months. All patients will be advised regular check-ups post surgically at per appointment . Individual study period will be 12 months. Total duration of study will be 15 months.

Primary outcomes:

Reduction in intra-bony defect angle and vertical bone loss. Periodontal and alveolar bone regeneration by detecting the levels of biomarkers namely, transforming growth factor β, osteocalcin

Secondary Outcomes:

Osteogenic proliferation : Evaluation of RUNX2 expression in response to Metformin \& Alendronate 1% gel administration will be assessed per subject per genetic analysis.

RUNX2 expression will be observed through RT- PCR.

Conditions

• Alveolar Bone Loss Associated Chronic Periodontitis

Interventions

PROCEDURE

Platelet rich fibrin

sub-gingival administration of platelet rich fibrin following open flap surgery

DRUG

Metformin hydrochloride powder

subgingival administration of 1% Metformin Hydrochloride gel with platelet rich fibrin following open flap surgery

DRUG

alendronate sodium powder

subgingival administration of 1% Alendronate gel with platelet rich fibrin following open flap surgery

Sponsors & Collaborators

• Islamabad Medical and Dental College

  collaborator OTHER

• Bahria University

  lead OTHER

Principal Investigators

• Mamoora Arslaan, MPhil · Bahria University Islamabad

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-22

Primary Completion

2026-02-14

Completion

2027-09-30

Countries

• Pakistan

Study Locations