Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis

NCT ID: NCT02283736

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root planning (SRP).

Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.

Detailed Description

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Conditions

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-Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Periodontal treatment, Probitic

Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.

Group Type EXPERIMENTAL

Lactobacillus rhamnosus SP1

Intervention Type OTHER

Tablet containing Lactobacillus rhamnosus SP1

Periodontal treatment

Intervention Type PROCEDURE

Scaling and root planning

Periodontal treatment, talc powder tab

Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Group Type PLACEBO_COMPARATOR

Talc powder

Intervention Type OTHER

Tablet containing talc powder

Periodontal treatment

Intervention Type PROCEDURE

Scaling and root planning

Interventions

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Lactobacillus rhamnosus SP1

Tablet containing Lactobacillus rhamnosus SP1

Intervention Type OTHER

Talc powder

Tablet containing talc powder

Intervention Type OTHER

Periodontal treatment

Scaling and root planning

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ≥14 natural teeth, excluding third molars
* ≥10 posterior teeth
* ≥35 years old
* ≥ 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm
* Bleeding on probing ≥20% of sites
* Extensive bone loss determined radiographically

Exclusion Criteria

* Periodontal treatment before the time of examination
* Systemic illness
* Pregnancy
* Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jorge Gamonal

OTHER

Sponsor Role lead

Responsible Party

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Jorge Gamonal

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jorge Gamonal, Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry of University of Chile

Locations

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Faculty of Dentistry of University of Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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FONDECYT 1130570

Identifier Type: -

Identifier Source: org_study_id

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