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

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ClinicalTrials.gov Identifier: NCT03692819
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho

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 chronic generalized periodontitis.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Complex Drug: Placebo Oral Tablet Drug: Amoxicillin 500 Mg Drug: Lactobacillus reuteri Oral Drops Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
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: Triple (Care Provider, Investigator, Outcomes Assessor)
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
Official Title: Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : May 3, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: Prodentis




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Plaque Index [ Time Frame: Baseline, 30, 90 and 180 days ]
    Number of teeth affected before and after periodontal treatment.

  2. Gingival Index [ Time Frame: Baseline,30,90 and 180 days ]
    Number of teeth affected before and after the treatment.

  3. Gingival Recession [ Time Frame: Baseline,30, 90 and 180 days ]
    Evaluated in milimeters before and after the treatment.

  4. Clinical Attachment Level [ Time Frame: Baseline,30, 90 and 180 days ]
    Evaluated in milimeters before and after the treatment.

  5. 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.

  6. 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.



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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692819


Contacts
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Contact: Maria Jardini, PhD 55 12 39479046 ext 551239479046 jardini@ict.unesp.br
Contact: Tatiane Ramos, DDS

Locations
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Brazil
Maria Jardini Recruiting
São José dos Campos, São Paulo, Brazil, 1224500
Contact: Maria Jardini, PhD    55 12 39479046    jardini@ict.unesp.br   
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Director: Maria Jardini, PhD Universidade Estadual Paulista Julio de Mesquita Filho

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Responsible Party: Maria Aparecida Neves Jardini, Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03692819     History of Changes
Other Study ID Numbers: Probioticos e Antibióticos
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho:
Chronic Periodontitis
Periodontal Debridement
Antibiotics
Probiotics

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents