Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Effectiveness of Scaling and Root Planing With and Without Minocycline Microspheres (Arestin) in Improving Periodontal and Glycemic Outcomes in Diabetic Patients With Periodontitis: A Randomized Controlled Trial
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Feb 2026
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedFirst Posted
Study publicly available on registry
December 22, 2025
CompletedStudy Start
First participant enrolled
February 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
February 19, 2026
February 1, 2026
1.3 years
December 11, 2025
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pocket Closure
Pocket Depth (PD ≤4 mm)
Baseline, 3 Months, 6 Months
Secondary Outcomes (2)
Changes in Glycemic Control (HbA1c)
Baseline, 3 Months, 6 Months
Changes in C-reactive Protein Level (CRP)
Baseline, 3 Months, 6 Months
Study Arms (2)
Test Group
EXPERIMENTALMinocycline microspheres (Arestin®) / (4 mg per cartridge) prefilled delivery syringe / Arestin will be placed in the pocket only one time after scaling and root planing.
Control Group
ACTIVE COMPARATORScaling and Root Planing Alone
Interventions
Scaling and Root planing + local application of Arestin ( Minocycline microsphere)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Use of antibiotics within the past 3 months
- Pregnancy or breastfeeding
- Morbid Obesity (BMI 40+)
- Smokers or patients with poorly controlled systemic diseases other than diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OraPharmacollaborator
- Case Western Reserve Universitylead
Study Sites (1)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Related Publications (3)
Skaleric U, Schara R, Medvescek M, Hanlon A, Doherty F, Lessem J. Periodontal treatment by Arestin and its effects on glycemic control in type 1 diabetes patients. J Int Acad Periodontol. 2004 Oct;6(4 Suppl):160-5.
PMID: 15536785RESULTSimpson TC, Clarkson JE, Worthington HV, MacDonald L, Weldon JC, Needleman I, Iheozor-Ejiofor Z, Wild SH, Qureshi A, Walker A, Patel VA, Boyers D, Twigg J. Treatment of periodontitis for glycaemic control in people with diabetes mellitus. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD004714. doi: 10.1002/14651858.CD004714.pub4.
PMID: 35420698RESULTPreshaw PM, Alba AL, Herrera D, Jepsen S, Konstantinidis A, Makrilakis K, Taylor R. Periodontitis and diabetes: a two-way relationship. Diabetologia. 2012 Jan;55(1):21-31. doi: 10.1007/s00125-011-2342-y. Epub 2011 Nov 6.
PMID: 22057194RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gian Pietro Schincaglia, DDS, PhD
Case Western Reserve University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2025
First Posted
December 22, 2025
Study Start
February 6, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data (IPD) will not be shared with other researchers. Only de-identified, cumulative data (summary-level results) will be shared with the study sponsor (OraPharma) after study completion. No identifiable participant information such as name, date of birth, or contact details will be disclosed. All collected data will remain securely stored within Case Western Reserve University and will only be accessed by the study investigators and authorized university or regulatory personnel.