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Completed

NCT Number: NCT03692819

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

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.

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Key information

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Jardini

São José dos Campos, São Paulo, 1224500, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo oral tablet

Drug

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

Other names: Periodontal debridement

Amoxicillin 500 Mg

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

Other names: Metronidazole Oral

Lactobacillus reuteri Oral Drops

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.

Other names: Prodentis

Primary outcomes

  1. 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.

Secondary outcomes

  1. Plaque Index

    Time frame: Baseline, 30 and 90 days

    Number of teeth affected before and after periodontal treatment.

  2. Gingival Index

    Time frame: Baseline, 30 and 90 days

    Number of teeth affected before and after the treatment.

  3. Gingival Recession

    Time frame: Baseline, 30 and 90 days

    Evaluated in milimeters before and after the treatment.

  4. Clinical Attachment Level

    Time frame: Baseline, 30 and 90 days

    Evaluated in milimeters before and after the treatment.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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