Phase 2 Recruiting NCT06204455

Local antibiotic delivery for severe periodontitis

University of California, San Francisco · Interventional, Randomized 1:1 · n=120

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Medicine Dental Caries (Tooth Decay)

Overview

Subgingival application of doxycycline-loaded biodegradable polymer fibers as adjunct to scaling and root planing. This Phase 2 study compares clinical attachment gain at 12 weeks against scaling/root planing alone in patients with severe periodontitis (stage III–IV).

Full record on ClinicalTrials.gov (NCT ID NCT06204455).

Eligibility

Inclusion criteria

- Age ≥ 30 years - Diagnosis of stage III or IV periodontitis - Probing depth ≥ 6 mm at ≥ 2 sites per quadrant - Non-smoker or able to abstain during study period

Exclusion criteria

- Antibiotic use within the prior 3 months - Uncontrolled diabetes (HbA1c > 8%) - Pregnancy or breastfeeding - Known doxycycline allergy

Age range: ≥ 30 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase: Phase 2
Study type: Interventional
Allocation: Randomized 1:1
Masking: Double-blind (participant and outcomes assessor)
Intervention model: Parallel assignment
Primary purpose: Treatment
Enrollment target: 120 participants
Started: May 2025
Estimated completion: March 2027

Outcome measures

Primary endpoint

Clinical attachment level gain at 12 weeks

Secondary endpoints

- Probing depth reduction at 12 and 24 weeks - Bleeding on probing reduction - Patient-reported oral health quality of life

Locations & contacts

Showing 4 of 4 sites

4 sites currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

UCSF School of Dentistry — San Francisco, CA

Principal Investigator: Mark I. Ryder, DMD · Status: Recruiting

University of Washington School of Dentistry — Seattle, WA

Principal Investigator: Frank A. Roberts, DDS · Status: Recruiting

Tufts University School of Dental Medicine — Boston, MA

Principal Investigator: Steven A. Friedman, DDS · Status: Recruiting

University of Michigan School of Dentistry — Ann Arbor, MI

Principal Investigator: William V. Giannobile, DDS · Status: Recruiting

Sources

REG

ClinicalTrials.gov — NCT06204455

Trial registry · primary record