Evaluation of Subgingival 1% Metformin Gel Versus 0.05% Zoledronate Gel as an Adjunct to MINST of Intrabony Defects in Controlled Type 2 DM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: All participants will receive MINST.
- Who it may be relevant to
- Registry conditions: Controlled Type 2 Diabetic Patients With Periodontitis. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Procedure All participants will receive MINST
using ultrasonic scalers and hand curettes over two sessions within 1 week.
Primary outcome measures
- Radiographic intra-bony defect depth [Time frame: 6 months]
Secondary outcome measures (2)
- Clinical attachment level [Time frame: 6 months]
- Periodontal pocket depth (PPD) [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07753317 · MTIERU