Clinical, microbiological, and immunological effects of 3-or 7-day systemic antibiotics adjunctive to subgingival instrumentation in patients with aggressive (Stage III/IV Grade C) periodontitis: A randomized placebo-controlled clinical trial

Cosgarea, Raluca; Jepsen, Soren; Heumann, Christian; Batori-Andronescu, Ionela; Rosu, Alexandra; Bora, Raluca; Arweiler, Nicole B.; Eick, Sigrun und Sculean, Anton (2022): Clinical, microbiological, and immunological effects of 3-or 7-day systemic antibiotics adjunctive to subgingival instrumentation in patients with aggressive (Stage III/IV Grade C) periodontitis: A randomized placebo-controlled clinical trial. In: Journal of Clinical Periodontology, Bd. 49, Nr. 11: S. 1106-1120

Abstract

Aim To evaluate the clinical non-inferiority of a 3-day protocol of systemic antibiotics adjunctive to subgingival instrumentation (SI) compared with a 7-day-protocol in patients with Stage III/IV Grade C periodontitis. Materials and Methods Fifty systemically healthy patients (32.7 +/- 4.3 years) with aggressive periodontitis (AgP;Stage III/IV Grade C periodontitis) were treated by SI and adjunctive amoxicillin and metronidazole and were randomly assigned to Group A: (n = 25) 500 mg antibiotics (AB) 3 times a day for 3 days, followed by placebo 3 times a day for 4 days, or Group B: (n = 25) 500 mg AB 3 times a day for 7 days. Clinical, microbial, and immunological parameters were assessed at baseline, 3 months, and 6 months, and patient-related outcomes were assessed after 2 weeks. The primary outcome variable was the number of residual sites with pocket depth (PD) >= 6 mm at 6 months. Results For the primary outcome variable (the number of residual sites with PD >= 6 mm at 6 months), the null hypothesis was rejected and non-inferiority of the 3-day AB protocol compared with the 7-day AB protocol was demonstrated (the upper limits of the 95% confidence interval for intention to treat analysis: [-2.572;1.050] and per protocol analysis: [-2.523;1.318] were lower than the assumed margin of Delta = 3.1). Comparable clinical improvements were obtained for all parameters with both antibiotic protocols (p > .05). All investigated periodontopathogens and pro-inflammatory host-derived markers were statistically significantly reduced without differences between the treatments (p > .05). Conclusions These findings indicate that in patients with AgP (Stage III/IV Grade C periodontitis), a 3-day systemic administration of amoxicillin and metronidazole adjunctive to SI may lead to non-inferior clinical outcomes after 6-months with fewer adverse events compared with a 7-day-protocol.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Mathematik, Informatik und Statistik > Statistik
• Themengebiete: 500 Naturwissenschaften und Mathematik > 510 Mathematik
• ISSN: 0303-6979
• Sprache: Englisch