Periodontitis
Conditions
Brief summary
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.
Detailed description
The present study is a double-blinded randomized clinical trial with a duration of 12 weeks . 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline. The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks. Clinical measurements and sampling will be performed at baseline, week 6 and week 12. Primary endpoint: Changes in microbial composition. Secondary endpoints: Changes in clinical and immunological parameters
Interventions
DIETARY_SUPPLEMENTProbiotic
In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.
DIETARY_SUPPLEMENTPlacebo
In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis
Intervention model description
Double blinded randomized clinical trial with a test and placebo group
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Periodontitis stage 2-3, Grade B-C, generalized
Exclusion criteria
* • Use of systemic antibiotics within the latest three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in microbial composition in dental plaque | Baseline vs. week 6 and week 12 | Changes in alpha and beta diversity of microbial composition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in dental plaque | Baseline vs. week 6 and week 12 | Changes in mean level of dental plaque |
| Changes in bleeding on probing | Baseline vs. week 6 and week 12 | Changes in mean level of bleeding on probing |
| Changes in probing pocket depth | Baseline vs. week 6 and week 12 | Changes in mean level of probing pocket depth |
| Changes in clinical attachment level | Baseline vs. week 6 and week 12 | Changes in mean level of clinical attachment level |
| Changes in salivary levels of inflammatory cytokines | Baseline vs. week 6 and week 12 | Changes in mean salivary levels of selected inflammatory cytokines |
Countries
Denmark
Outcome results
None listed