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Non-Surgical Treatment of Peri-implantitis with Systemic Azithromycin or Placebo
Sponsor: University of Santiago de Compostela
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).
Official title: NON-SURGICAL TREATMENT of PERI-IMPLANTITIS with or WITHOUT SYSTEMIC AZITHROMYCIN: a RANDOMIZED CLINICAL TRIAL in HUMANS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2025-01-10
Completion Date
2027-01-10
Last Updated
2024-12-10
Healthy Volunteers
No
Conditions
Interventions
Azithromcyin
Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.
Placebo
Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.
Locations (1)
Department of Surgery and Medical-Surgical Specialties, Teaching and Research Unit in Periodontology. Faculty of Medicine and Dentistry, University of Santiago de Compostela.
Santiago de Compostela, A Coruña, Spain