NCT06856369

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

Active, enrolled Phase 4 Last updated 4 March 2025

What this trial tests

Phase 4 trial testing Platelet rich fibrin in Alveolar Bone Loss Associated Chronic Periodontitis in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 January 2025

Primary endpoint
14 February 2026

30 September 2027

Quick facts

Lead sponsor	Bahria University
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	22 January 2025
Primary completion	14 February 2026
Estimated completion	30 September 2027
Sites	1 location across Pakistan

Drugs / interventions tested

• Platelet rich fibrin — full drug profile →
• Metformin hydrochloride powder
• alendronate sodium powder

Conditions studied

• Alveolar Bone Loss Associated Chronic Periodontitis — all drugs for Alveolar Bone Loss Associated Chronic Periodontitis →

Sponsor

Bahria University

Who can join

Adults 30 to 50, any sex, with Alveolar Bone Loss Associated Chronic Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of metformin as an adjunct in periodontitis: A systematic analysis.
   Uddin MKH, Naseem A, Aziz SM, Rafiq S, et al · · 2026 · PMID 41953690 · DOI 10.1016/j.jtumed.2026.03.007