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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT06204185
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-11-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months.
1% Metformin	Metformin	1% Metformin Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sameh Magdy Abou El-Kheir; 🇪🇬 Cairo, Egypt