Systemic azithromycin as an adjunct to scaling and root planing in patients with stage III/IV periodontitis: 12-month results of a randomized controlled clinical trial.

Abstract

OBJECTIVES\nTo determine whether azithromycin (AZI) as an adjunct to scaling and root planing (SRP), when compared to placebo, decreases the number of sites demonstrating pocket depth (PD) ≥ 5 mm and bleeding on probing (BOP) 12 months post-treatment in stage III/IV periodontitis patients.\n\n\nMATERIALS AND METHODS\nIn a double-blind randomized parallel-arm placebo-controlled trial, 40 stage III/IV periodontitis patients received steps 1 and 2 of periodontal treatment in two sessions within 7 days. Patients then received systemic antibiotic therapy (n = 20; AZI 500 mg/day, 3 days) or placebo (n = 20). Additional instrumentation of residual diseased sites (DS)\xa0-\xa0sites with PD ≥ 5 mm and BOP\xa0-\xa0was performed at the 3-, 6- and 9-month follow-ups. The primary outcome variable was the number of DS at the 12-month re-evaluation. Using a multivariate multilevel logistic regression model, the effects of gender, age, antibiotic therapy, presence of Porphyromonas gingivalis or Aggregatibacter actinomycetemcomitans, smoking, tooth being a molar and interdental location were evaluated.\n\n\nRESULTS\nThe number of DS after 12 months was similar in the test (median (Me) = 4, interquartile range (IQR) = 0-6) and control (Me = 3, IQR = 1-6.5) groups. Both groups showed substantial but equivalent improvements in periodontal parameters, with no intergroup differences at initially shallow or deep sites. The logistic regression showed a lower odds ratio (OR) for the healing of DS on molars (OR = 0.29; p < 0.001) and in smokers (OR = 0.36; p = 0.048).\n\n\nCONCLUSION\nStage III/IV periodontitis patients showed significant but comparable improvements in periodontal parameters and the number of residual DS at the 12-month revaluation regardless of treatment type. This may have been the result of the additional instrumentation received by patients at residual DS in both treatment groups.\n\n\nCLINICAL RELEVANCE\nTreatment with AZI + SRP provided no additional benefits after 12 months in terms of periodontal parameters or the number of persisting sites with PD ≥ 5 mm + BOP as compared to SRP plus placebo.\n\n\nTRIAL REGISTRATION\nEUDRA-CT: 2015-004306-42; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004306-42/SI , registered 17. 12. 2015.