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Clinical and Biochemical Evaluation of 1% Metformin in Non-surgical Treatment of Periodontitis

Clinical and Biochemical Evaluation of the Use of Locally Delivered Metformin as an Adjunctive Therapy to Non Surgical Periodontal Treatment of Periodontitis Patients (Randomized Controlled Study)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06204185
Enrollment
40
Registered
2024-01-12
Start date
2019-02-01
Completion date
2022-11-30
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Brief summary

The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients

Interventions

DRUGMetformin

Locally delivered Metformin gel in the treatment of periodontitis patients

DRUGPlacebo

Placebo gel consist of drug without the active component.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Evaluate the clinical parameters ( Probing Depth, Clinical Attachment Level, Gingival and Plaque Indices) before & after the application of locally delivered metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with Stage III Grade A Periodontitis. * Systemically free according to the modified Burkitt's health history questionnaire, Group I. (Glick et al., 2021). * Good compliance with the plaque control instructions following initial therapy. * Availability for follow up and maintenance program.

Exclusion criteria

* Smokers * Pregnant and lactating females. * Vulnerable groups of patients' e.g (prisoners, handicapped patients and decisionally impaired individuals).

Design outcomes

Primary

MeasureTime frame
RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.Baseline and 1 month after the gel application

Secondary

MeasureTime frame
Plaque index (PI)Baseline, 3 Months and 6 Months post operatively.
Gingival Index (GI)Baseline, 3 Months and 6 Months post operatively.
Probing depth (PD)Baseline, 3 Months and 6 Months post operatively.
Clinical attachment level (CAL)Baseline, 3 Months and 6 Months post operatively.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026