Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
NCT ID: NCT07298057
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
42 participants
INTERVENTIONAL
2026-01-15
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test Group
Minocycline microspheres (Arestin®) / (4 mg per cartridge) prefilled delivery syringe / Arestin will be placed in the pocket only one time after scaling and root planing.
local antibiotic application of topical minocycline
Scaling and Root planing + local application of Arestin ( Minocycline microsphere)
Control Group
Scaling and Root Planing Alone
Scaling and Root Planing
Only scaling and root planing
Interventions
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local antibiotic application of topical minocycline
Scaling and Root planing + local application of Arestin ( Minocycline microsphere)
Scaling and Root Planing
Only scaling and root planing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with moderate to severe periodontitis (≥5 mm probing pocket depth in at least 6 distinct interproximal sites, on different teeth)
3. At least 16 teeth present
4. No periodontal treatment in the last 6 months
Exclusion Criteria
2. Unable to receive or to tolerate local anesthesia
3. Unable to tolerate tooth instrumentation with ultrasonic instruments.
4. Require IV sedation to receive scaling and root planing
5. Use of antibiotics within the past 3 months
6. Pregnancy or breastfeeding
7. Morbid Obesity (BMI 40+)
8. Smokers or patients with poorly controlled systemic diseases other than diabetes
18 Years
ALL
No
Sponsors
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OraPharma
INDUSTRY
Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Gian Pietro Schincaglia, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Case Western Reserve University
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Gian Pietro Schincaglia, DDS, PhD
Role: primary
References
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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.
Simpson 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.
Preshaw 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.
Other Identifiers
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STUDY20250753
Identifier Type: -
Identifier Source: org_study_id