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Completed

NCT Number: NCT06204185

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

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

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sameh Magdy Abou El-Kheir

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

metformin

Drug

Locally delivered Metformin gel in the treatment of periodontitis patients

Placebo

Drug

Placebo gel consist of drug without the active component.

Primary outcomes

  1. 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.

    Time frame: Baseline and 1 month after the gel application

Secondary outcomes

  1. Plaque index (PI)

    Time frame: Baseline, 3 Months and 6 Months post operatively.

  2. Gingival Index (GI)

    Time frame: Baseline, 3 Months and 6 Months post operatively.

  3. Probing depth (PD)

    Time frame: Baseline, 3 Months and 6 Months post operatively.

  4. Clinical attachment level (CAL)

    Time frame: Baseline, 3 Months and 6 Months post operatively.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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