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

NCT ID: NCT03692819

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2020-09-20

Brief Summary

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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

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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.

Conditions

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Chronic Periodontitis Complex

Keywords

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Chronic Periodontitis Periodontal Debridement Antibiotics Probiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.

Metronidazole and Amoxicillin

Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days.

Group Type EXPERIMENTAL

Amoxicillin 500 Mg

Intervention Type DRUG

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

Lactobacillus reuteri

Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days.

Group Type EXPERIMENTAL

Lactobacillus reuteri Oral Drops

Intervention Type DRUG

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.

Interventions

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Placebo Oral Tablet

Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.

Intervention Type 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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Periodontal debridement Metronidazole Oral Prodentis

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role lead

Responsible Party

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Maria Aparecida Neves Jardini

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Jardini, PhD

Role: STUDY_DIRECTOR

Universidade Estadual Paulista Julio de Mesquita Filho

Locations

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Maria Jardini

São José dos Campos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Probioticos e Antibióticos

Identifier Type: -

Identifier Source: org_study_id