Phase 3
N=42
Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes
Periodontitis · Periodontal Pocket · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03374176 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Probing Depth — 0.44; 0.50 mm — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amoxicillin 500 mg / Metronidazole 250 mg (Drug); Clindamycin 300 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centro Universitario de Tonalá
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probing Depth |
0.44; 0.50 | <0.05 sig |
| SECONDARY Sites With Plaques |
17.6; 15.8 | — |
| SECONDARY Sites With Bleeding on Probing |
16.1; 22.1 | — |
| SECONDARY Total Count of All Teeth Lost Across All Participants |
0; 0 | — |
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
Eligibility Criteria
Inclusion Criteria
- Patients of both sexes
- Age >18 to 70 years
- Diagnosis of chronic periodontitis according to the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions
- History of type 2 diabetes
- HbA1C < 8 %
- Fasting plasma glucose (FPG) < 180 mg/dL.
Exclusion Criteria
- Aggressive periodontitis
- Pregnant or lactating females,
- Required antibiotic pre-medication for the performance of periodontal examination and treatment or received antibiotic treatment in the previous 3 months were excluded.
- A history of anti-inflammatory therapy within preceding six months
- Had received a course of periodontal treatment within the last 6 months,
- Allergies to penicillin, metronidazole or clindamycin,
- Not able to provide consent to participate in the study
Data sourced from ClinicalTrials.gov (NCT03374176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.