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

Primary Purpose

Peri-implantitis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Probiotic - BioGaia
Placebo
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implantitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZLeuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test

Control

Arm Description

Probiotic tablet

Control tablet

Outcomes

Primary Outcome Measures

Probing Pocket Depth (PPD) at peri-implantitis sites
Pocket probing depth measured with Merrit-B probe

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2015
Last Updated
February 12, 2019
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
BioGaia AB
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1. Study Identification

Unique Protocol Identification Number
NCT02520401
Brief Title
The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
Official Title
The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
BioGaia AB

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Probiotic tablet
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control tablet
Intervention Type
Other
Intervention Name(s)
Probiotic - BioGaia
Intervention Description
Use of a probiotic tablet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Use of a placebo tablet
Primary Outcome Measure Information:
Title
Probing Pocket Depth (PPD) at peri-implantitis sites
Description
Pocket probing depth measured with Merrit-B probe
Time Frame
Baseline - 6 months
Secondary Outcome Measure Information:
Title
Bleeding on Probing (BoP) at peri-implantitis sites
Description
Binairy outcome: 0: no bleeding, 1: bleeding
Time Frame
Baseline - 6 months
Title
Plaque at peri-implantitis sites
Description
Binairy outcome: 0: no plaque, 1: plaque
Time Frame
Baseline - 6 months
Title
Microbial samples
Description
Of tongue coating, saliva and peri-implantitis site
Time Frame
Baseline - 6 months
Title
Full mouth plaque score (FMPS)
Description
Binairy outcome: 0: no plaque, 1: plaque
Time Frame
Baseline - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UZLeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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