The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis

NCT ID: NCT02520401

Last Updated: 2019-02-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-12-31

Brief Summary

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This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Detailed Description

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This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. 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 departement of Periodontology at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria will be asked to participate in this study.

Conditions

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Peri-implantitis

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 - BioGaia

Intervention Type OTHER

Use of a probiotic tablet

Control

Control tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Use of a placebo tablet

Interventions

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Probiotic - BioGaia

Use of a probiotic tablet

Intervention Type OTHER

Placebo

Use of a placebo tablet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>18 years of age
* Patients with at least one implant\* diagnosed with initial peri-implantitis.
* Willing and able to give written informed consent
* No signs of acute periodontitis
* presence of keratinized tissue around treated implant(s)

Exclusion Criteria

* patients who smoke
* patients with periodontitis
* pregnant or lactating woman
* patients with poorly controlled diabetes
* patients taking bisphosphonate mediation
* patient who had taken systemic antibiotics 3 months prior to treatment
* peri-implantitis treatment 12 months prior intake
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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s57668

Identifier Type: -

Identifier Source: org_study_id

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