Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to MINST of Intrabony Defects in Controlled Type 2 DM

August 9, 2026 updated by: Parryhan Mohamed Abdelsamie, Cairo University

Clinical and Radiographic Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to Minimally Invasive Nonsurgical Treatment of Intrabony Defects in Controlled Type 2 Diabetic Patients With Periodontitis. A Placebo Randomized Controlled Trial.

The present randomized placebo-controlled trial aims to evaluate and compare the clinical and radiographic efficacy of subgingivally delivered 0.05% zoledronate gel and 1% metformin gel as adjuncts to minimally invasive nonsurgical treatment of intrabony defects in patients with controlled type 2 diabetes mellitus and periodontitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus, with HbA1c levels <7.0% (controlled).
  • Diagnosis of chronic periodontitis (Stage III/IV, Grade B/C) with at least one intrabony defect of ≥3 mm depth, PPD ≥5 mm, and CAL ≥4 mm measured with a calibrated UNC-15 probe.
  • Angular bone loss of ≥3 mm measured on digital intraoral periapical radiographs and having three walled intrabony defects without involving furcation confirmed on cone beam computed tomography (CBCT).

Exclusion Criteria:

  1. Smokers.
  2. Pregnant or lactating women.
  3. Patients on systemic bisphosphonate therapy or other medications known to affect bone metabolism.
  4. Uncontrolled diabetes (HbA1c >8%) or other systemic diseases that could affect periodontal status.
  5. History of radiation therapy to the head and neck

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subgingival administration of 0.05% zoledronate gel
MINST will be performed followed by Subgingival administration of 0.05% zoledronate gel
Procedure: All participants will receive MINST
using ultrasonic scalers and hand curettes over two sessions within 1 week.
Active Comparator: Subgingival administration of 1% metformin gel
MINST will be performed followed by Subgingival administration of 1% metformin gel
Procedure: All participants will receive MINST
using ultrasonic scalers and hand curettes over two sessions within 1 week.
Placebo Comparator: Subgingival administration of placebo gel
MINST will be performed followed by Subgingival administration of placebo gel
Procedure: All participants will receive MINST
using ultrasonic scalers and hand curettes over two sessions within 1 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic intra-bony defect depth
Time Frame: 6 months
The radiographic IBD depth will be measured by computer-aided software program, IBD depth will be measured on the radiograph by measuring the vertical distance from the crest of the alveolar bone to the base of the defect
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: 6 months
measured from the cementoenamel junction (CEJ) to the bottom of pocket.
6 months
Periodontal pocket depth (PPD)
Time Frame: 6 months
will be recorded from the gingival margin to the base of the pocket
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Egyptian Russian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 7, 2026

Primary Completion (Estimated)

February 7, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 7, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 9, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTIERU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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