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

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07753317

Enrollment

Registered

2026-08-07

Start date

2026-08-07

Completion date

2027-03-01

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Controlled Type 2 Diabetic Patients With Periodontitis

Keywords

Metformin gel, Zoledronate gel, nonsurgical treatment, Intrabony Defects, type 2 diabetes, Periodontitis

Brief summary

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

PROCEDUREAll participants will receive MINST

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Radiographic intra-bony defect depth	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

Secondary

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

Contacts

CONTACTParryhan M Abdelsamie

Parryhan.abdelsamie@dentistry.cu.edu.eg01003082353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026