Active — Not RecruitingPhase 4

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

Pakistan120 participantsStarted 2025-01-22

Plain-language 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.

Who can participate

Age range30 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Males and females * Age 25-50 years * Systemically healthy individuals * Probing depth sites ≥ 5mm- \<7 mm pocket depth (PD)\[American Dental Association/ Academy of Periodontology 1999) Clinical attachment level (CAL) ≥4mm- \<5 mm \[ American Dental Association/ Academy of Periodontology 1999) * Vertical bone loss (VBL) ≥3mm on intraoral periapical radiographs.\[American Academy of Periodontology Guidelines, 1999\] * Modified Sulcus bleeding index (mSBI) \[Muhlemann and Sons index,1971; Augusta B Rebelo et al,2011\] * No history of periodontal treatment in the previous 6 months Exclusion Criteria: * • Individuals \<20 and \>50 yrs * Patients with known systemic disease such as diabetes, hypertension, osteoporosis etc. * Patients with severe periodontitis * Pregnant and lactating mothers * Patients receiving medications

What they're measuring

Reduction in intra-bony defect depth in millimeters in patients suffering from chronic periodontitis

Timeframe: 6, 9 & 12 months

Trial details

NCT IDNCT06856369

SponsorBahria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-14