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

November 13, 2020 updated by: Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São José dos Campos, São Paulo, Brazil, 1224500
        • Maria Jardini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Placebo Oral Tablet
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
Other Names:
  • Periodontal debridement
Experimental: Metronidazole and Amoxicillin
Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days.
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
Other Names:
  • Metronidazole Oral
Experimental: Lactobacillus reuteri
Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 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.
Other Names:
  • Prodentis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Probing Depth change
Time Frame: Baseline, 30 and 90 days
The change in the probing depth will be measure in millimeters before and after the treatment.
Baseline, 30 and 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: Baseline, 30 and 90 days
Number of teeth affected before and after periodontal treatment.
Baseline, 30 and 90 days
Gingival Index
Time Frame: Baseline, 30 and 90 days
Number of teeth affected before and after the treatment.
Baseline, 30 and 90 days
Gingival Recession
Time Frame: Baseline, 30 and 90 days
Evaluated in milimeters before and after the treatment.
Baseline, 30 and 90 days
Clinical Attachment Level
Time Frame: Baseline, 30 and 90 days
Evaluated in milimeters before and after the treatment.
Baseline, 30 and 90 days
Periodontal Inflamed Surface Area (PISA)
Time Frame: Baseline, 30 and 90 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.
Baseline, 30 and 90 days
Microbiological Parameters
Time Frame: Baseline, 30 and 90 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.
Baseline, 30 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Jardini, PhD, Universidade Estadual Paulista Julio de Mesquita Filho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Probioticos e Antibióticos

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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