The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy

NCT ID: NCT02490618

Last Updated: 2019-02-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

Detailed Description

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The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.

Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.

Selection of the study population: Adults, who consult at the department of Periodontology at the University Hospital Leuven, and who fit the inclusion criteria will be asked to participate in this study.

Conditions

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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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Test

Probiotic tablet

Group Type EXPERIMENTAL

Probiotic tablet- Biogaia

Intervention Type OTHER

Control

Control tablet

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type OTHER

Interventions

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Probiotic tablet- Biogaia

Intervention Type OTHER

Placebo tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 40 patients
* ≥ 18 years of age
* scaling and rootplaning received at least 3 months ago
* Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:\> 5mm or 5 and BOP+
* Willing and able to give written informed consent

Exclusion Criteria

* patients with aggressive periodontitis
* patients who smoke
* pregnant or lactating woman
* patients with poorly controlled diabetes
* patients taking bisphosphonate mediation
* patient who had taken systemic antibiotics 3 months prior to treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioGaia AB

INDUSTRY

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZLeuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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s57667

Identifier Type: -

Identifier Source: org_study_id

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