Clinical Trial: The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
Brief Summary: This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.
Detailed Summary:
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.
Sponsor: Universitaire Ziekenhuizen Leuven
Current Primary Outcome: Probing Pocket Depth (PPD) at peri-implantitis sites [ Time Frame: Baseline - 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Bleeding on Probing (BoP) at peri-implantitis sites [ Time Frame: Baseline - 6 months ]Binairy outcome: 0: no bleeding, 1: bleeding
- Plaque at peri-implantitis sites [ Time Frame: Baseline - 6 months ]Binairy outcome: 0: no plaque, 1: plaque
- Microbial samples [ Time Frame: Baseline - 6 months ]Of tongue coating, saliva and peri-implantitis site
- Full mouth plaque score (FMPS) [ Time Frame: Baseline - 6 months ]Binairy outcome: 0: no plaque, 1: plaque
Original Secondary Outcome: Same as current
Information By: Universitaire Ziekenhuizen Leuven
Dates:
Date Received: May 6, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: November 14, 2016
Last Verified: November 2016