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

Chronic Periodontitis Complex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692819
• Other study ID #: Probioticos e Antibióticos
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: September 20, 2020

Study information

• Verified date: November 2020
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Chronic Periodontitis Complex
• Periodontitis

Intervention

Drug:
• Placebo Oral Tablet
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
• 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
• 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.

Locations

Country	Name	City	State
Brazil	Maria Jardini	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plaque Index	Number of teeth affected before and after periodontal treatment.	Baseline, 30 and 90 days
Secondary	Gingival Index	Number of teeth affected before and after the treatment.	Baseline, 30 and 90 days
Secondary	Gingival Recession	Evaluated in milimeters before and after the treatment.	Baseline, 30 and 90 days
Secondary	Clinical Attachment Level	Evaluated in milimeters before and after the treatment.	Baseline, 30 and 90 days
Secondary	Periodontal Inflamed Surface Area (PISA)	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
Secondary	Microbiological Parameters	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