Periodontitis
Conditions
Brief summary
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.
Detailed description
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated. Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. 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 department of Periodontology at the University Hospital Leuven, and who fit the inclusion criteria will be asked to participate in this study.
Interventions
OTHERProbiotic tablet- Biogaia
OTHERPlacebo 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
* 40 patients * ≥ 18 years of age * scaling and rootplaning received at least 3 months ago * Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:\> 5mm or 5 and BOP+ * Willing and able to give written informed consent
Exclusion criteria
* patients with aggressive periodontitis * patients who smoke * pregnant or lactating woman * patients with poorly controlled diabetes * patients taking bisphosphonate mediation * patient who had taken systemic antibiotics 3 months prior to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pocket Probing Depth (PPD) at teeth with residual pockets | 3-6 months |
| Recessions (REC) at teeth with residual pockets | 3-6 months |
| Clinical Attachment Loss (CAL) at teeth with residual pockets | 3-6 months |
Secondary
| Measure | Time frame |
|---|---|
| Microbial samples: deepest pocket, saliva, tongue | 3-6 months |
| Plaque at teeth with residual pockets | 3-6 months |
| Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) | 3-6 months |
| Bleeding on Probing (BoP) at teeth with residual pockets | 3-6 months |
| Overall PPD, REC, CAL | 3-6 months |
Countries
Belgium
Outcome results
None listed