Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.

Study Overview
=================
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.

Official Title
-----------------
Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.

Conditions
-----------------
Chronic Periodontitis Complex

Intervention / Treatment
-----------------
* Drug: Placebo Oral Tablet
* Drug: Amoxicillin 500 Mg
* Drug: Lactobacillus reuteri Oral Drops


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: placebo<br>Periodontal debridement treatment will be performed in a single session after the therapy will be administered the Placebo Oral Tablet twice a day for 21 days. | Drug: Placebo Oral Tablet<br>* Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.<br>* Other names: Periodontal debridement;|
| Experimental: Metronidazole and Amoxicillin<br>Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days. | Drug: Amoxicillin 500 Mg<br>* 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<br>* Other names: Metronidazole Oral;|
| Experimental: Lactobacillus reuteri<br>Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days. | Drug: Lactobacillus reuteri Oral Drops<br>* 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.<br>* Other names: Prodentis;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth change | The change in the probing depth will be measure in millimeters before and after the treatment. | Baseline, 30 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Number of teeth affected before and after periodontal treatment. | Baseline, 30 and 90 days | 
| Gingival Index | Number of teeth affected before and after the treatment. | Baseline, 30 and 90 days | 
| Gingival Recession | Evaluated in milimeters before and after the treatment. | Baseline, 30 and 90 days | 
| Clinical Attachment Level | Evaluated in milimeters before and after the treatment. | Baseline, 30 and 90 days | 
| Periodontal Inflamed Surface Area (PISA) | Is calculated from data collected on probing the periodontal pocket and are placed in a table which gives the value of the periodontal inflamed surface area. | Baseline, 30 and 90 days | 
| Microbiological Parameters | crevicular fluid samples will be analyzed by PCR (real time PCR) for detection and quantification of: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Lactobacillus reuteri. | Baseline, 30 and 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Periodontitis, Periodontal Debridement, Antibiotics, Probiotics