ClinicalTrials.gg
RecruitingNCT07298057Updated Feb 19, 2026

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

An Early Phase 1 interventional study of local antibiotic application of topical minocycline and Scaling and Root Planing in Periodontitis, Diabetes Mellitus Type 2, sponsored by Case Western Reserve University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Case Western Reserve University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.

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Phase
Early Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 75 studies in Periodontitis with a site in United States — 13 open to participants now, 16 under way, none of them phase 3. Periodontitis · United States.

Planned enrollment
39th of 56
42 · median 58
Started
2026
with 3 others
Phase 1
5 of 75
2 open now
Primary completion
2027-06
later than 11 of 14 live
Registered
72nd of 75
by date

Among the 75 studies in Periodontitis with a site in United States, this one is the 39th largest by planned enrollment of the 56 interventional ones that give a count, is one of 4 that started in 2026, is one of 5 in phase 1, reaches primary completion later than 11 of the 14 other live ones, and was the 72nd registered.

Periodontitis

1,235 studies on the registry are indexed under Periodontitis; 298 are open to participants now.

Browse Periodontitis studies →

Open to participants now

13 of the 75 studies in Periodontitis with a site in United States are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 160 Periodontitis studies recruiting now, 79 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 77 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Periodontitis, Diabetes Mellitus Type 2

Keywords

  • Scaling and Root Planing
  • Arestin
  • Diabetes Mellitus Type 2
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Exclusion Criteria:

  1. Allergy to minocycline or tetracycline
  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 ( 40+)
  8. Smokers or patients with poorly controlled systemic diseases other than diabetes
Terms in these criteria, in plain language(2)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: local antibiotic application of topical minocycline

  • Active comparator
    Control Group

    Scaling and Root Planing Alone

    Procedure: Scaling and Root Planing

Interventions

  • Druglocal antibiotic application of topical minocycline

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

    Also known as: Arestin Minocicline microsphere

  • ProcedureScaling and Root Planing

    Only scaling and root planing

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
    Recruiting
    • Gian Pietro Schincaglia, DDS, PhD · Contactgxs486@case.edu · 216-368-4412
    • Gian Pietro Schincaglia, DDS, PhD · Principal investigator
08

References and documents

Publications

  • 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. PubMed 15536785 ↗
  • 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. PubMed 35420698 ↗
  • 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. PubMed 22057194 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Jun 2027, 16 months after the start.

Of 27 phase 1 interventional studies under Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 16 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2025
First posted
Dec 22, 2025
StartActual
Feb 6, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2028
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07298057
Collaborators
OraPharma
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Feb 6, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Feb 19, 2026

Study contacts

Gian Pietro Schincaglia, DDS, PhD
Contact
gxs486@case.edu
216-368-4412
Gian Pietro Schincaglia, DDS, PhD
principal investigator · Case Western Reserve University

Oversight

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

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