Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes
Condition: Periodontitis; Periodontal Pocket; Diabetes Mellitus
MeSH terms: Periodontitis; Periodontal Pocket; Diabetes Mellitus
Intervention: Amoxicillin 500 mg / Metronidazole 250 mg; Clindamycin 300 mg
Intervention description: Subjects were instructed to take a capsule three times a day for 7 days; Subjects were instructed to take a capsule three times a day for 7 days
Intervention MeSH terms: Amoxicillin; Metronidazole; Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: periodontitis; diabetes mellitus; systemic antimicrobials

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