Clinical trial NCT03692819: Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
Official title: Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis Complex
Keywords: Chronic Periodontitis
Periodontal Debridement
Antibiotics
Probiotics
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Individuals between 35 and 50 years of age;
* Be diagnosed with generalized chronic periodontitis: present a loss of interproximal clinical insertion\> 3 mm in 2 nonadjacent teeth and loss of interproximal clinical insertion ≥5 mm, in 30% or more of the teeth present;
* Present at least 16 teeth;
* Present good systemic health;
* Agree to participate in the study and sign the informed consent form

Exclusion Criteria:

* Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, among others), which do not indicate the periodontal procedure;
* Have undergone periodontal treatment in the last twelve months;
* Have used antibiotics and/or anti-inflammatories for the past six months;
* Smoking patients;
* Pregnancy or Lactation;
* Chronic use of medications that may alter the response of periodontal tissues.

Primary outcomes:
measure: Probing Depth change
timeFrame: Baseline, 30 and 90 days
Secondary outcomes:
measure: Plaque Index
timeFrame: Baseline, 30 and 90 days
measure: Gingival Index
timeFrame: Baseline, 30 and 90 days
measure: Gingival Recession
timeFrame: Baseline, 30 and 90 days
measure: Clinical Attachment Level
timeFrame: Baseline, 30 and 90 days
measure: Periodontal Inflamed Surface Area (PISA)
timeFrame: Baseline, 30 and 90 days
measure: Microbiological Parameters
timeFrame: Baseline, 30 and 90 days
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: Maria Jardini
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista Julio de Mesquita Filho
name: Maria Jardini, PhD
role: STUDY_DIRECTOR
References: