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

February 12, 2019 updated by: Universitaire Ziekenhuizen KU Leuven
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Probiotic tablet
Other: Probiotic - BioGaia
Use of a probiotic tablet
Placebo Comparator: Control
Control tablet
Other: Placebo
Use of a placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Pocket Depth (PPD) at peri-implantitis sites
Time Frame: Baseline - 6 months
Pocket probing depth measured with Merrit-B probe
Baseline - 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing (BoP) at peri-implantitis sites
Time Frame: Baseline - 6 months
Binairy outcome: 0: no bleeding, 1: bleeding
Baseline - 6 months
Plaque at peri-implantitis sites
Time Frame: Baseline - 6 months
Binairy outcome: 0: no plaque, 1: plaque
Baseline - 6 months
Microbial samples
Time Frame: Baseline - 6 months
Of tongue coating, saliva and peri-implantitis site
Baseline - 6 months
Full mouth plaque score (FMPS)
Time Frame: Baseline - 6 months
Binairy outcome: 0: no plaque, 1: plaque
Baseline - 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

BioGaia AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s57668

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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