Systemic Azithromycin as an Adjunct to Non-Surgical Subgingival Instrumentation in the Treatment of Stage III/IV, Grade C Periodontitis: 12-Month Clinical, Microbiological and Cytokine Results of a Randomised Controlled Trial.

Abstract

Aim: To evaluate the clinical, microbial and cytokine changes following the use of oral azithromycin as an adjunct to non-surgical subgingival instrumentation (NSI) in stage III/IV, grade C periodontitis through a triple-blind, parallel-armed, randomised controlled trial.

Material and methods: A total of 52 patients with stage III/IV grade C periodontitis were randomly allocated to two groups receiving NSI with or without adjunctive azithromycin. The primary outcome was changes in the periodontal inflamed surface area (PISA) values over 12 months, and the secondary outcomes included changes in pocket depth (PD), clinical attachment loss (CAL), percentage of sites with PD of 1-3, 4-5, ≥ 5 and ≥ 6 mm, subgingival periodontal pathogens, cytokine levels and patient-reported outcomes.

Results: At 3 and 12 months, there were no statistically significant differences in the reduction in PISA or other clinical parameters between the groups. At 3 months, the levels of several periodontal pathogens were significantly reduced in the azithromycin group. No significant differences were observed in the levels of periodontal pathogens at 12 months except for Prevotella intermedia. No significant differences were observed for the studied cytokines at 3 and 12 months.

Conclusion: The results of this study do not support the use of systemic azithromycin in stage III/IV, grade C periodontitis.

Trial registration: The trial was registered prospectively in the Australia New Zealand Clinical Trial Registry, ACTRN12619000560190. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374699.