Clinical Trial

Non-Surgical Treatment of Peri-implantitis with Systemic Azithromycin or Placebo

Study acronym: NSTP
Not Yet Recruiting Phase 4
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Record status
This record was last updated December 10, 2024 (before its estimated January 10, 2026 completion). Its status may not reflect the trial's current state.
Summary
The primary objective of this study is to evaluate the change in probing depth in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) adjunctive to non-surgical treatment at 12 months. The secondary objective is to assess clinical, radiographic, microbiological, and systemic changes at 3, 6, and 12 months. This study is designed as a placebo-controlled, randomized, triple-blind clinical trial in subjects diagnosed with peri-implantitis. The treatment will consist of debridement of the implant surface and curettage of the pocket epithelium. The control group will receive placebo (1 placebo tablet per day for 3 days), and the test group will receive systemic azithromycin 500 mg per day for 3 days (1 tablet of 500 mg azithromycin per day for 3 days).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-02.
Trial Details
NCT Number NCT06715150
Lead Sponsor University of Santiago de Compostela
Conditions Peri-implantitis
Enrollment 52 participants
Start Date 2025-01-10
Primary Completion 2026-01-10 (estimated)
Study Completion 2027-01-10 (estimated)
Updated on ClinicalTrials.gov 2024-12-10