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

Periodontitis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06204185
• Other study ID #: FD-ASUREC.IM011967
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• Metformin
Locally delivered Metformin gel in the treatment of periodontitis patients
• Placebo
Placebo gel consist of drug without the active component.

Locations

Country	Name	City	State
Egypt	Sameh Magdy Abou El-Kheir	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plaque index (PI)		Baseline, 3 Months and 6 Months post operatively.
Secondary	Gingival Index (GI)		Baseline, 3 Months and 6 Months post operatively.
Secondary	Probing depth (PD)		Baseline, 3 Months and 6 Months post operatively.
Secondary	Clinical attachment level (CAL)		Baseline, 3 Months and 6 Months post operatively.