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

NCT06856369 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: BUHS-IRB#125/24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic periodontitis; intra-bony defect depth; metformin; alendronate; platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

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

  Assessment will be done at 6, 9 \& 12 months using Orthopantomogram

  6, 9 & 12 months

Secondary Outcomes (1)

• Osteogenic proliferation

  3 months

Study Arms (3)

Platelet Rich Fibrin

ACTIVE COMPARATOR

Group A - administration of Platelet rich fibrin only, subgingivally , once in 6 months

Procedure: Platelet rich fibrin

Metformin

ACTIVE COMPARATOR

Group -B - Platelet Rich Fibrin +1% Metformin gel, once sub-gingivally in 6 months

Drug: Metformin hydrochloride powder

Alendronate

ACTIVE COMPARATOR

Group C- Platelet rich fibrin + 1% Alendronate gel , once sub-gingivally in 6 months

Drug: alendronate sodium powder

Interventions

Platelet rich fibrin PROCEDURE

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

Platelet Rich Fibrin

Metformin hydrochloride powder DRUG

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

Metformin

alendronate sodium powder DRUG

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

Alendronate

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahria University: lead
• Islamabad Medical and Dental College: collaborator

Study Sites (1)

Islamabad Medical & Dental College

Islamabad, Federal, 04408, Pakistan

Location

Related Publications (4)

• Arena C, Caponio VCA, Zhurakivska K, Lo Russo L, Lo Muzio L, Troiano G. Added effect of 1% topical alendronate in intra-bony and inter-radicular defects as part of step II periodontal therapy: a systematic review with meta-analysis and trial sequential analysis. BMC Oral Health. 2022 Jan 21;22(1):15. doi: 10.1186/s12903-022-02044-1.

  PMID: 35062940 RESULT

• Ozcan E, Saygun I, Kantarci A, Ozarslanturk S, Serdar MA, Ozgurtas T. The effects of a novel non-invasive application of platelet-rich fibrin on periodontal clinical parameters and gingival crevicular fluid transforming growth factor-beta and collagen-1 levels: A randomized, controlled, clinical study. J Periodontol. 2021 Sep;92(9):1252-1261. doi: 10.1002/JPER.20-0713. Epub 2021 Jan 15.

  PMID: 33382101 RESULT

• Hu J, Han J, Jin M, Jin J, Zhu J. Effects of metformin on bone mineral density and bone turnover markers: a systematic review and meta-analysis. BMJ Open. 2023 Jun 23;13(6):e072904. doi: 10.1136/bmjopen-2023-072904.

  PMID: 37355276 RESULT

• Chang J, Blanchard SB, Windsor LJ, Gregory RL, Hamada Y. Levels of growth factors from platelet-rich fibrin from chronic periodontitis versus periodontally healthy subjects: a pilot study. Clin Oral Investig. 2020 Feb;24(2):823-832. doi: 10.1007/s00784-019-02944-7. Epub 2019 Jun 13.

  PMID: 31197657 RESULT

Related Links

• PMID: 35062940

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mamoora Arslaan, MPhil

  Bahria University Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 4, 2025
• Study Start: January 22, 2025
• Primary Completion: February 14, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD data will become accessible one year after publication and will remain available indefinitely
• Access Criteria: all data will be accessible to every one

Locations

PA (1)