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OpenTrials
Completed

NCT Number: NCT02520401

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZLeuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic - BioGaia

Other

Use of a probiotic tablet

Placebo

Other

Use of a placebo tablet

Primary outcomes

  1. Probing Pocket Depth (PPD) at peri-implantitis sites

    Time frame: Baseline - 6 months

    Pocket probing depth measured with Merrit-B probe

Secondary outcomes

  1. Bleeding on Probing (BoP) at peri-implantitis sites

    Time frame: Baseline - 6 months

    Binairy outcome: 0: no bleeding, 1: bleeding

  2. Plaque at peri-implantitis sites

    Time frame: Baseline - 6 months

    Binairy outcome: 0: no plaque, 1: plaque

  3. Microbial samples

    Time frame: Baseline - 6 months

    Of tongue coating, saliva and peri-implantitis site

  4. Full mouth plaque score (FMPS)

    Time frame: Baseline - 6 months

    Binairy outcome: 0: no plaque, 1: plaque

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • BioGaia AB

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2015
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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