Peri-implantitis
Conditions
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.
Interventions
OTHERProbiotic - BioGaia
Use of a probiotic tablet
OTHERPlacebo
Use of a placebo tablet
Sponsors
BioGaia AB
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth (PPD) at peri-implantitis sites | Baseline - 6 months | Pocket probing depth measured with Merrit-B probe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Probing (BoP) at peri-implantitis sites | Baseline - 6 months | Binairy outcome: 0: no bleeding, 1: bleeding |
| Plaque at peri-implantitis sites | Baseline - 6 months | Binairy outcome: 0: no plaque, 1: plaque |
| Microbial samples | Baseline - 6 months | Of tongue coating, saliva and peri-implantitis site |
| Full mouth plaque score (FMPS) | Baseline - 6 months | Binairy outcome: 0: no plaque, 1: plaque |
Countries
Belgium
Outcome results
None listed