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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Maria Aparecida Neves Jardini，Universidade Estadual Paulista Júlio de Mesquita Filho

Tracking Information

First Submitted Date ^ICMJE

September 6, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

May 2, 2018

Estimated Primary Completion Date

May 3, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Probing Depth change[ Time Frame: 30, 90 and 180 days ]

The change in the probing depth will be measure in millimeters before and after the treatment.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Plaque Index[ Time Frame: Baseline, 30, 90 and 180 days ]
Number of teeth affected before and after periodontal treatment.
Gingival Index[ Time Frame: Baseline,30,90 and 180 days ]
Number of teeth affected before and after the treatment.
Gingival Recession[ Time Frame: Baseline,30, 90 and 180 days ]
Evaluated in milimeters before and after the treatment.
Clinical Attachment Level[ Time Frame: Baseline,30, 90 and 180 days ]
Evaluated in milimeters before and after the treatment.
Periodontal Inflamed Surface Area (PISA)[ Time Frame: Baseline,30, 90 and 180 days ]
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.
Microbiological Parameters[ Time Frame: Baseline,30, 90 and 180 days ]
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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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 microbiological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of chronic generalized periodontitis. Patients will be randomized into 3 groups: Group 1 (n=17): periodontal debridement, Group 2 (n=17): periodontal debridement associated with antibiotic (Metronidazole 400 mg + Amoxicillin 500mg) and Group 3 (n=17): 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 microbiological data obtained before and after periodontal therapy (baseline, 30, 90 and 180 days) 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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Prospective double-blind randomized controlled clinical study with a 180-days follow-up.
Masking: Interventional
Masking Description:In addition to concealment of randomization, the investigator responsible for the procedures of periodontal therapy (periodontal debridement) and the researcher responsible for the measurements will not know which treatment each group will receive, characterizing the blindness of the study.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Placebo Oral Tablet
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
Drug: Amoxicillin 500 Mg
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
Drug: Lactobacillus reuteri Oral Drops
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.

Study Arms

Active Comparator: placebo
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.
Experimental: Metronidazole and Amoxicillin
Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days.
Experimental: Lactobacillus reuteri
Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 1, 2019

Estimated Primary Completion Date

May 3, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

35 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Brazil

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Maria Aparecida Neves Jardini，Universidade Estadual Paulista Júlio de Mesquita Filho

Study Sponsor ^ICMJE

Universidade Estadual Paulista Júlio de Mesquita Filho

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Maria Jardini, PhD Universidade Estadual Paulista Julio de Mesquita Filho

PRS Account

Universidade Estadual Paulista Júlio de Mesquita Filho

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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