Eine prospektive klinische Studie zur Antibiotikatherapie und deren Auswirkungen auf odontogene Abszesse ohne Ausbreitungstendenz

1. Abstract 1.1. Background & Objectives Odontogenic abscesses are a common clinical picture in dentistry and require rapid therapy, oth-erwise they can quickly lead to life-threatening complications. To date, there is no gold standard for the therapy of a localized odontogenic abscess. As a result, dentists tend to prescribe antibiotics as maximum therapy. Due to the increasing resistance to antibiotics, this approach is considered problematic and requires a solution. Therefore, the aim of this study was to find out how the adjuvant administration of an antibiotic, in addition to sur-gical therapy, affects the healing process in patients with a localized odontogenic abscess with-out evidence of dissemination. 1.2. Design & Methods In this double-blind cohort study, patients meeting the inclusion criteria with an odontogenic abscess were enrolled. These patients presented at the Department of Oral and Maxillofacial Surgery in Erlangen between October 2018 and April 2021. Patients who had not received antibiotic treatment prior to their first appointment at the Depart-ment were randomly assigned, in a double-blind manner, to either group 1a or group 2. Patients allocated to group 1a received an antibiotic, while those in group 2 were administered a placebo. Group 1b consisted of patients who had already received antibiotic treatment before their initial appointment at the Department. This group was therefore not subject to randomized or blinded assignment. The administration of antibiotics for group 1b was carried out in the same manner as for group 1a. The overall group 1 comprises both groups 1a and 1b, including all patients who received anti-biotic therapy during the study, regardless of the time of administration or method of group allo-cation. When the study refers to this combined group configuration, it is termed the cohort vari-ant: “Cohort”. When an analysis considers both the timing of antibiotic administration and the method of group assignment, it becomes necessary to differentiate between the subgroups 1a and 1b. In this case, the configuration is referred to as the “Extended Cohort”. Thus, two cohort variants are considered in the statistical analysis: • Cohort variant: focuses on the aggregate analysis of antibiotic-treated patients, grouped together as overall group 1. • Extended cohort variant: focuses on a differentiated analysis that considers the timing of antibiotic administration, through subdivision into groups 1a and 1b. Patients were assessed during a follow-up period of five days over the course of three appoint-ments: • the day of surgery and abscess drainage (first appointment) • the second postoperative day (second appointment) • the fourth postoperative day (third appointment). At each appointment, a blood sample was taken to determine C-reactive protein (CRP) levels and leukocyte count. Additionally, body temperature was measured, and patients quantified their experienced pain using a visual analogue scale (VAS). Furthermore, it was documented during abscess drainage whether pus or infiltrate was discharged. The type and timing of focus restoration were recorded. The secondary parameters discharge of pus or infiltrate, nicotine abuse and prior intake of anti-inflammatory medications were statistically analyzed in relation to group affiliation and the CRP and leukocyte count pa-rameters. Statistical analysis was performed using IBM SPSS Statistics. 1.3. Observations & Results A total of n = 73 patients was included in the cohort study. Group 1 overall consisted of n = 41 patients, and group 2 included n = 32 patients. In the following analysis, not all 73 patients are considered at all times. Only those patients with a complete dataset for the parameters (CRP, leukocyte count, temperature, and VAS) across all three appointments are included in the statistical evaluation. At the beginning of treatment, the CRP level was elevated in the majority of patients (group 1 overall: n = 92 %, group 2: n = 82.1 %). Repeated measurements revealed no significant differ-ence between the two groups. The factor “time” had a significant influence on the reduction of CRP levels over the observation period (p ≤ 0.001). Leukocyte counts showed no statistically significant differences with respect to group assign-ment over the observation period. In both groups, the mean leukocyte count was lower in smokers compared to non-smokers. VAS values showed a clear reduction in pain across both groups over the course of the obser-vation period; however, there were no significant differences between the groups (p >>> 0.05). The initial VAS score was lowest in group 1b (VAS 1 – group 1a: 5.74, group 1b: 4.33, group 2: 5.61); however, the scores converged over time. The anamnesis parameters: discharge of pus or infiltrate, smoking history, and prior intake of anti-inflammatory medication, did not significantly affect the overall healing process (p >>> 0.05). 1.4. Discussion & Conclusion The aim of this study was to examine whether the adjuvant use of an antibiotic positively influ-ences the healing process of an odontogenic abscess. After analysis of all results, no benefit of the use of an antibiotic could be determined. However, due to a lack of significance, no clear contraindication could either be established. Only the temporal component is decisive for heal-ing. Due to the small number of subjects, the quality or evidence of this study is downgraded. In order to establish a new gold standard in abscess therapy, further studies with a similar experi-mental design and larger patient population should be performed.