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Systemic Probiotics in the Periodontal Treatment

NCT03733379 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2020-01-13

No results posted yet for this study

Summary

The aim of this multicenter randomized clinical trial is to evaluate the clinical, microbiological and immunological effects of probiotics as an adjunct to Scaling and Root Planing alone or in combination with Metronidazole and Amoxicillin in the treatment of periodontitis.

Conditions

  • Periodontitis

Interventions

PROCEDURE

Scaling and root planing

SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.

DRUG

Metronidazole and Amoxicillin placebos

Amoxicillin and metronidazole placebos thrice a day for 14 days (beginning with the first SRP session).

DRUG

Metronidazole

Metronidazole 400 mg thrice a day for 14 days (beginning with the first SRP session).

DRUG

Amoxicillin

Amoxicillin 500 mg thrice a day for 14 days (beginning with the first SRP session).

DIETARY_SUPPLEMENT

Probiotic

The probiotic contains 2 different strains of Lactobacillus reuteri: L.reuteri DSM 17938 and L. reuteri ATCC PTA 5289 each at a concentration of 1 x 108 CFU per tablet. It will be used 2 times per day by 90 days.

DIETARY_SUPPLEMENT

Probiotic placebo

The placebo is identical to the active but without L. reuteri. The two Study Products are identical in taste, texture and shape. It will be used 2 times per day by 90 days.

Sponsors & Collaborators

  • Belén Retamal-Valdes

    lead OTHER

Principal Investigators

  • Magda Feres, Professor · University of Guarulhos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2020-12-30
Completion
2021-12-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03733379 on ClinicalTrials.gov