ClinicalTrials.gg
Not yet recruitingNCT07753317Updated Aug 11, 2026

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

An interventional study of All participants will receive MINST in Controlled Type 2 Diabetic Patients With Periodontitis, sponsored by Cairo University. Not yet recruiting. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Controlled Type 2 Diabetic Patients With Periodontitis

Keywords

  • Metformin gel
  • Zoledronate gel
  • nonsurgical treatment
  • Intrabony Defects
  • type 2 diabetes
  • Periodontitis
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with type 2 diabetes mellitus, with 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

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 ( >8%) or other systemic diseases that could affect periodontal status.
  5. History of radiation therapy to the head and neck
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

  • Placebo comparator
    Subgingival administration of placebo gel

    MINST will be performed followed by Subgingival administration of placebo gel

    Procedure: All participants will receive MINST

Interventions

  • ProcedureAll participants will receive MINST

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

06

What researchers measure

Primary outcomes

  1. Radiographic intra-bony defect depth

    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

    Time frame: 6 months

Secondary outcomes

  1. Clinical attachment level

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

    Time frame: 6 months

  2. Periodontal pocket depth (PPD)

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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07753317
Lead sponsor
Cairo University
Collaborators
Egyptian Russian University
Responsible party
Parryhan Mohamed Abdelsamie (Lecturer of periodontology, MTI University) — Principal investigator
First posted
Aug 7, 2026
Start date
Aug 7, 2026 (estimated)
Primary completion
Feb 7, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Parryhan M Abdelsamie
Contact
Parryhan.abdelsamie@dentistry.cu.edu.eg
01003082353

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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