Effect of Periodontal Therapy in association with Probiotic in the microbial communities of the mouth and intestine.

Phase 2

Recruiting

• Conditions: Chronic Periodontitis, Periodontitis; C07.465.714.533.324; C07.465.714.533

• Registration Number: RBR-2vjvxv
• Lead Sponsor: Faculdade de Odontologia da Universidade Federal do Rio de Janeiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Subjects with eighteen years or more; who have at least fourteen natural teeth, excluding third molars; and advanced chronic periodontitis which is determined as pocket probing depth equal or greater than six mm in three or more periodontal sites and bleeding on probing in twenty percent of the sites examined.

Exclusion Criteria

Exclusion criteria are the need for antibiotic prophylaxis; having received antibiotics therapy in the three-month period prior to the study; having received periodontal therapy in the six-month period prior to the study; chronic gastrointestinal diseases or abnormalities of the gastrointestinal tract; metabolic disorders; cardiovascular diseases; immunological disorders; HIV infection; be a smoker or have stopped smoking in less than
five years; ongoing orthodontic treatment; have Body Mass Index equal or greater than twenty-five; be pregnant or breastfeeding, if woman.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in intestinal alpha diversity after nonsurgical periodontal treatment, measured by feces microbiological profile showing 0.6% increase in alpha diversity.<br>Data collected previously to periodontal therapy and 2, 6 and 12 months after finishing periodontal therapy. <br>

Secondary Outcome Measures

Name	Time	Method
Increase in intestinal alpha diversity after nonsurgical periodontal treatment and probiotic use, measured by feces microbiological profile showing increase in alpha diversity higher than 0.6%.; Difference at mean pocket probing depth between the group that use probiotic and the group that used placebo. Data viewed by mean pocket probing depth in probiotic group being 1 mm lower than placebo group.