Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
Condition: Chronic Periodontitis Complex
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Currently, with the increase of bacterial resistance to antibiotics associated with its side
      effects, it is necessary to find other adjuncts to combat the disease that are an alternative
      to the use of antibiotics. The use of probiotics has been proposed in the literature as an
      adjunct therapy for the treatment of periodontal diseases, however, few controlled and
      randomized clinical studies have been performed. The objective of this double-blind
      randomized controlled trial will be to evaluate the response of clinical and microbiological
      periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and
      probiotic) for the treatment of stages II and III grade B periodontitis.
    

Detailed description: 
      Currently, with the increase of bacterial resistance to antibiotics associated with its side
      effects, it is necessary to find other adjuncts to combat the disease that are an alternative
      to the use of antibiotics. The use of probiotics has been proposed in the literature as an
      adjunct therapy for the treatment of periodontal diseases, however, few controlled and
      randomized clinical studies have been performed. The objective of this double-blind
      randomized controlled trial will be to evaluate the response of clinical and immunological
      periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and
      probiotic) for the treatment of stages II and III grade B periodontitis. Patients will be
      randomized into 3 groups: Group 1 (n=15): periodontal debridement, Group 2 (n=15):
      periodontal debridement associated with antibiotic (Metronidazole 400 mg + Amoxicillin 500mg)
      and Group 3 (n=15): periodontal debridement associated with probiotic (Lactobacillus
      reuteri). Clinical (plaque index, gingival index, probing depth, gingival recession, relative
      clinical attachment level and periodontal inflamed surface area (PISA) index) and
      immunological data obtained before and after periodontal therapy (baseline, 30 and 90) will
      be consolidated and made available on average ± standard deviation and normality tested using
      the Shapiro-Wilk test. For statistical analysis, the software BioEstat 5.0 (Belém, PA,
      Brazil) will be used, with p-value < 0,05.
    

Intervention name(s): Placebo Oral Tablet; Amoxicillin 500 Mg; Lactobacillus reuteri Oral Drops
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.; Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the antibiotic (Metronidazole 400mg + Amoxicillin 500mg) every 8 hours for 7 days; Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the probiotic (Lactobacillus reuteri oral drops ) twice a day for 21 days.
Other intervention name(s): Periodontal debridement; Metronidazole Oral; Prodentis
Intervention MeSH terms: Amoxicillin; Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Periodontitis; Periodontal Debridement; Antibiotics; Probiotics