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).
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;
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;
Parallel
Azithromcyin
DrugImmediately 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
Other interventionImmediately 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.
Change in probing depth
The change in probing depth (quantitative dependent variable) at 12 months will be measured in millimeters as the distance from the mucosal margin to the bottom of the peri-implant pocket, using a millimetric CP15 UNC Hu-Friedy probe. The change in probing depth will also be measured at 3 and 6 months.
Recession
Distance from the implant shoulder to the margin of the peri-implant mucosa, measured in millimeters using a millimetric CP15 UNC Hu-Friedy probe. If the margin of the peri-implant mucosa is located apically to the implant shoulder, it will be recorded as a positive value (+); conversely, if the margin of the peri-implant mucosa is located coronally to the implant shoulder, it will be recorded as a negative value (-)
Clinical attachment level
Distance from the implant shoulder to the bottom of the peri-implant pocket (probing depth + recession) measured in millimeters using a millimetric CP15 UNC Hu-Friedy probe
Bleeding index
0: absent bleeding / 1: present bleeding
Plaque index
0: absent plaque / 1: present plaque
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