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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Santiago de Compostela

About this trial

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).

Eligibility criteria

Qualifiers

older than 18 years;

absence of systemic pathology contraindicating treatment;

presence of at least 1 implant diagnosed with peri-implantitis: presence of bleeding on probing, probing depth ≥6 mm, and radiographic bone level ≥3 mm apical to the most coronal portion of the intraosseous part of the implant;

absence of implant mobility;

Disqualifiers

smokers ≥10 cigarettes/day;

diabetic patients (HbA1c level ≥6,5%);

pregnant or breastfeeding women;

use of antibiotics, corticosteroids, and/or immunosuppressive treatment in the 3 months prior to the start of the study;

Trial design

Treatments tested in this trial

  • Azithromcyin
  • Placebo

Treatment groups

52 Participants
are divided into 2 treatment groups