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

Conditions

• Alveolar Bone Loss Associated Chronic Periodontitis

Eligibility Criteria

Sex

ALL

Age

30 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Platelet rich fibrin — PROCEDURE
  sub-gingival administration of platelet rich fibrin following open flap surgery
• Metformin hydrochloride powder — DRUG
  subgingival administration of 1% Metformin Hydrochloride gel with platelet rich fibrin following open flap surgery
• alendronate sodium powder — DRUG
  subgingival administration of 1% Alendronate gel with platelet rich fibrin following open flap surgery

Study Details

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.

Key Dates

Start date

Jan 22, 2025

Status verified

Jan 2025

Primary completion

Feb 14, 2026

Completion

Sep 30, 2027

Study Design

Enrollment

120 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Platelet Rich Fibrin
  Group A - administration of Platelet rich fibrin only, subgingivally , once in 6 months
• Active Comparator: Metformin
  Group -B - Platelet Rich Fibrin +1% Metformin gel, once sub-gingivally in 6 months
• Active Comparator: Alendronate
  Group C- Platelet rich fibrin + 1% Alendronate gel , once sub-gingivally in 6 months

Primary Outcome Measure

Reduction in intra-bony defect depth in millimeters in patients suffering from chronic periodontitis [ Time Frame: 6, 9 & 12 months ]