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

Study acronym: NSTP
StatusNot Yet Recruiting
PhasePhase 4
Started
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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.

Record History

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  1. Lead sponsor: Juan Blanco Carrión to University of Santiago de Compostela
    • Secondary endpoints revised (18)
    • Study title shortened, about 10 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06715150
Lead Sponsor University of Santiago de Compostela
Conditions
(from sponsor)		 Peri-implantitis
Related terms Peri-Implantitis
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov