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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

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Abstract

Objectives

To 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.

Materials and methods

In 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) — sites with PD ≥ 5 mm and BOP — was 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.

Results

The 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).

Conclusion

Stage 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.

Clinical relevance

Treatment 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.

Trial registration

EUDRA-CT: 2015-004306-42; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004306-42/SI, registered 17. 12. 2015.

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Funding

The study was supported by the Ministry of Science and Technology of the Republic of Slovenia, grant number P3-0293.

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Contributions

Katarina Čuk and Katja Povšič performed the statistical analysis, article drafting and article revision; Suzana Milavec performed the clinical procedures; Vanja Erčulj performed the statistical analysis and article drafting; Katja Seme performed the microbiological analysis; Rok Gašperšič performed the conception and design of the study, clinical procedures, data acquisition and article drafting. All authors have read and approved the final manuscript. Parts of the present manuscript represent the content of an undergraduate student research project of Katarina Čuk and Katja Povšič.

Corresponding author

Correspondence to Katja Povšič.

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Ethics approval and consent to participate

All procedures involving human participants were in accordance with the ethical standards of the 1964 Helsinki declaration and the Code of Medical Ethics of the Medical Association of Slovenia. The study protocol was reviewed by the National Medical Ethic Committee (46/08/15) of the Republic of Slovenia. It was also registered at EUDRA-CT: 2015-004306-42.

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Informed consent was obtained from all individual participants included in the study.

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The authors declare no competing interests.

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Povšič, K., Čuk, K., Milavec, S. et al. 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. Clin Oral Invest 25, 5997–6006 (2021). https://doi.org/10.1007/s00784-021-03906-8

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