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NCT Number: NCT07753317

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

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.

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Key information

Conditions

Controlled Type 2 Diabetic Patients With Periodontitis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

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

Treatment and study plan

All participants will receive MINST

Procedure

using ultrasonic scalers and hand curettes over two sessions within 1 week.

Primary outcomes

  1. Radiographic intra-bony defect depth

    Time frame: 6 months

    Defect depth will be calculated as the length of the DB-CEJ line measured at baseline and follow-up radiographs from bone defect's deepest section to the point where the line between alveolar crest and the long axis of the tooth line intersects.

    Defect angle will be measured as the angle formed between the lateral defect boundary and the lines joining CEJ to bone defect's deepest section at baseline

Secondary outcomes

  1. Clinical attachment level

    Time frame: 6 months

    measured from the cementoenamel junction (CEJ) to the bottom of pocket.

  2. Periodontal pocket depth (PPD)

    Time frame: 6 months

    will be recorded from the gingival margin to the base of the pocket

Study contacts

Contact information is provided by the study sponsor or research team.

Parryhan M Abdelsamie

CONTACT

[email protected]

01003082353

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Egyptian Russian University

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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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