CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Amoxicillin 500 mg / Metronidazole 250 mg +1 moredrug
Likely dose
Amoxicillin 500 mg / Metronidazole 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03374176
NCT03374176Phase 3Completed

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

Centro Universitario de Tonalá·interventional·Posted Dec 15, 2017·Updated Sep 16, 2020

In Brief

A Phase 3 clinical trial evaluating Amoxicillin 500 mg / Metronidazole 250 mg and Clindamycin 300 mg for Periodontitis and 2 related conditions. Completed, enrolled 42 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 15, 2017
Enrollment StartMar 1, 2014
Primary CompletionJul 1, 2016
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.5 years ago

Interventions

Amoxicillin 500 mg / Metronidazole 250 mgdrug

Subjects were instructed to take a capsule three times a day for 7 days

Clindamycin 300 mgdrug

Subjects were instructed to take a capsule three times a day for 7 days