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

NCT03692819 | Completed

• 1 other identifier: Probioticos e Antibióticos
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 stages II and III grade B periodontitis.

Conditions

Chronic Periodontitis Complex

Keywords

Chronic Periodontitis; Periodontal Debridement; Antibiotics; Probiotics

Outcome Measures

Primary Outcomes (1)

• Probing Depth change

  The change in the probing depth will be measure in millimeters before and after the treatment.

  Baseline, 30 and 90 days

Secondary Outcomes (6)

• Plaque Index

  Baseline, 30 and 90 days

• Gingival Index

  Baseline, 30 and 90 days

• Gingival Recession

  Baseline, 30 and 90 days

• Clinical Attachment Level

  Baseline, 30 and 90 days

• Periodontal Inflamed Surface Area (PISA)

  Baseline, 30 and 90 days

Study Arms (3)

placebo

ACTIVE COMPARATOR

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

Metronidazole and Amoxicillin

EXPERIMENTAL

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

Drug: Amoxicillin 500 Mg

Lactobacillus reuteri

EXPERIMENTAL

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

Drug: Lactobacillus reuteri Oral Drops

Interventions

Placebo Oral Tablet DRUG

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

Also known as: Periodontal debridement

placebo

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

Also known as: Metronidazole Oral

Metronidazole and Amoxicillin

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.

Also known as: Prodentis

Lactobacillus reuteri

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Maria Jardini

São José dos Campos, São Paulo, 1224500, Brazil

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Periodontal Debridement; Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Maria Jardini, PhD

  Universidade Estadual Paulista Julio de Mesquita Filho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: October 2, 2018
• Study Start: May 2, 2018
• Primary Completion: August 20, 2020
• Study Completion: September 20, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)