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

NCT06715150 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Santiago de Compostela

Phase

Phase 4

Started

2025-01-10

Last updated

2024-12-10

Condition(s) studied

Peri-implantitis

Investigational drug(s) / intervention(s)

Azithromcyin →Placebo

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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; * patients without periodontitis or with treated periodontitis; * patients who understand the treatment and are willing to comply with it by providing written informed consent. Exclusion Criteria: * 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; * allergy to azithromycin; * patients with a history of bisphosphonate treatment; * chronic consumption of non-steroidal anti-inflammatory drugs; * bone loss exceeding the apex of the implant; * prosthesis that does not allow access to peri-implantitis treatment

Primary outcome measure(s)

Change in probing depth — From enrollment to the end of treatment at 12 months
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.

Trial sites (1)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06715150 on ClinicalTrials.gov ↗ ← All trials in Spain