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

NCT06204185 | Completed

• 1 other identifier: FD-ASUREC.IM011967
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

Outcome Measures

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.

  Baseline and 1 month after the gel application

Secondary Outcomes (4)

• 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.

Study Arms (2)

1% Metformin

ACTIVE COMPARATOR

1% Metformin Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months.

Drug: Metformin

Control Group

PLACEBO COMPARATOR

Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months.

Drug: Placebo

Interventions

Metformin DRUG

Locally delivered Metformin gel in the treatment of periodontitis patients

1% Metformin

Placebo DRUG

Placebo gel consist of drug without the active component.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Sameh Magdy Abou El-Kheir

Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer - Faculty of Dentistry - Delta University for Science and Technology

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: February 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: November 30, 2022
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

EG (1)