drugset / Trial / NCT03374176

Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes

NCT03374176

Phase 3 Completed 42 enrolled Centro Universitario de Tonalá
RandomizedParallel-groupTriple-blindTreatment

Summary

Periodontitis is an inflammation of the supporting structures of the teeth, usually caused by specific or groups of microorganisms that results in the progressive destruction of the periodontal ligament and alveolar bone. the objective of periodontitis treatment is to reduce the number of periodontal pathogens. However, there is not an agreement in the use of systemic antibiotics in patients with diabetes. The purpose of the present study was to determine the efficacy of amoxicillin/metronidazole compared to clindamycin during non-surgical treatment of periodontitis in patients with type 2 diabetes mellitus. Patients and methods In this double-blind, randomized clinical trial, a total of 42 patients with chronic periodontitis and type 2 diabetes were included in a 24-months follow-up. Patients were randomly assigned to treatment with either amoxicillin/metronidazole or clindamycin every for 7 days. Clinical determinations (depth of probing, bleeding at the probe and plaque index) were performed to determine the extent and severity of periodontitis before and after the pharmacological treatment. The intra-group differences were calculated with Wilcoxon rank test. The inter-group differences were calculated with Mann-Whitney test. Sex, bacterial plaque, and bleed to the sounding were summarized using proportions and analyzed with the chi-square method. In all analyses, a P-value of \<0.05 (two tailed) was considered statistically significant

Timeline

Start
2014-03
Primary completion
2016-07
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 500 mg Oral
Subject Clindamycin Unknown 300 mg Oral
Comparator Metronidazole Small molecule 250 mg Oral