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Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics

ConditionPeriodontitis, Diabetes Mellitus Type 2
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Western Reserve University

About this trial

Periodontitis is a prevalent chronic inflammatory disease that exacerbates systemic inflammation and poses challenges for glycemic control in diabetic patients. While scaling and root planing (SRP) remains the cornerstone of periodontal therapy, adjunctive treatments such as Arestin (minocycline microspheres) have shown promise in enhancing clinical outcomes. This study aims to evaluate the impact of adding Arestin to SRP on periodontal pocket closure, glycemic control, and systemic inflammation in diabetic patients with periodontitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years) with type 2 diabetes mellitus (HbA1c ≥ 7.0% and ≤9.5%)

Diagnosed with moderate to severe periodontitis (≥5 mm probing pocket depth in at least 6 distinct interproximal sites, on different teeth)

At least 16 teeth present

No periodontal treatment in the last 6 months

Disqualifiers

Allergy to minocycline or tetracycline

Unable to receive or to tolerate local anesthesia

Unable to tolerate tooth instrumentation with ultrasonic instruments.

Require IV sedation to receive scaling and root planing

Trial design

Design model

Parallel

Treatments tested in this trial

  • local antibiotic application of topical minocycline

    Drug

    Scaling and Root planing + local application of Arestin ( Minocycline microsphere)

  • Scaling and Root Planing

    Procedure/Surgery

    Only scaling and root planing

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pocket Closure

Pocket Depth (PD ≤4 mm)

Time frame
Baseline, 3 Months, 6 Months

Secondary outcomes

1

Changes in Glycemic Control (HbA1c)

Changes in Blood Sugar Level

Time frame
Baseline, 3 Months, 6 Months
2

Changes in C-reactive Protein Level (CRP)

Changes in Systemic Inflammation

Time frame
Baseline, 3 Months, 6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Western Reserve University

Lead sponsor

OraPharma

Collaborator

Source ClinicalTrials.gov
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