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

Impact of Nonsurgical Periodontal Therapy in association with Probiotic in the intestinal and oral microbiome: a randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-2vjvxv
Enrollment
Unknown
Registered
2018-10-18
Start date
2018-10-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis, Periodontitis

Interventions

Nonsurgical periodontal treatment in association with probiotic Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus casei, Lactobacillus salivarus, Lactobacillus plantarum, Lactobacillus
Procedure/surgery
Dietary supplement
E06.721.189.350
G07.203.300.456.500
D26.660

Sponsors

Faculdade de Odontologia da Universidade Federal do Rio de Janeiro
Lead Sponsor
Instituto de Microbiologia Paulo Góes da Universidade Federal do Rio de Janeiro
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
Increase in intestinal alpha diversity after nonsurgical periodontal treatment, measured by feces microbiological profile showing 0.6% increase in alpha diversity. Data collected previously to periodontal therapy and 2, 6 and 12 months after finishing periodontal therapy.

Secondary

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactAdriana Miranda de Oliveira

Faculdade de Odontologia da Universidade Federal do Rio de Janeiro

oliveira_am@ufrj.br55 21 980120542

Outcome results

None listed

Source: REBEC (via WHO ICTRP)