Influence of adjunctive azithromycin on microbiological and clinical outcomes in periodontitis patients: 6-month results of randomized controlled clinical trial

BACKGROUND: Our aim was to determine if azithromycin therapy, as an adjunct to scaling and root planing (SRP), decreases the number of pathobiontic subgingival plaque species and sites demonstrating pocket depth (PD) ≥ 5 mm and bleeding on probing (BOP) 6 months post-treatment. METHODS: In a double-blind randomized parallel-arm placebo-controlled trial, 40 patients received nonsurgical periodontal treatment in two sessions within 7 days. Patients then received systemic antibiotic therapy (n = 20, azithromycin 500 mg/day for 3 days) or placebo (n = 20). Pooled microbiologic samples were taken before and 6 months after therapy and analysed by established culture methods. The primary outcome variable was the number of sites with PD ≥ 5 mm and BOP at the 6-month re-evaluation. Using multivariate multilevel logistic regression, the effects of gender, age, antibiotic therapy, presence of P. gingivalis or A. actinomycetemcomitans, smoking, tooth being a molar and interdental location were evaluated. RESULTS: The number of sites with PD ≥ 5 mm and BOP after 6 months was similar in the test (Me = 4, IQR = 0–11) and control (Me = 5, IQR = 1–22) group. Adjunctive azithromycin treatment, compared to SRP alone, resulted in more frequent eradication of A. actinomycetemcomitans (p = 0.013) and C. rectus (p = 0.029), decreased proportion (p = 0.006) and total counts (p = 0.003) of P. gingivalis, and decreased proportion of C. rectus (p = 0.012). Both groups showed substantial but equivalent improvements in periodontal parameters, with no intergroups differences at initially shallow or deep sites. The logistic regression showed a lower odds ratio for healing of diseased sites on molars (OR = 0.51; p < 0,001). CONCLUSION: Despite significant changes in numbers of A. actinomycetemcomitans, P. gingivalis and C. rectus, patients with periodontitis do not benefit from adjunctive systemic azithromycin in terms of number of persisting sites with PD ≥ 5 mm and BOP. TRIAL REGISTRATION: EUDRA-CT: 2015–004306-42; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004306-42/SI, registered 17. 12. 2015.