Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Probiotic tablet |
|
| Control | Placebo Comparator | Control tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic tablet- Biogaia | Other |
| ||
| Placebo tablet |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque at teeth with residual pockets | 3-6 months | |
| Bleeding on Probing (BoP) at teeth with residual pockets | 3-6 months | |
| Overall PPD, REC, CAL |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZLeuven | Leuven | 3000 | Belgium |
Not provided
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3-6 months |
| Microbial samples: deepest pocket, saliva, tongue | 3-6 months |
| Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) | 3-6 months |