Gingivitis
Conditions
Brief summary
The present study is a double-blinded randomized clinical trial with a duration of 28 days.
Detailed description
The present study is a double-blinded randomized clinical trial with a duration of 28 days. 80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline. The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care. Clinical measurements and sampling will be performed at baseline, day 14 and day 28 Primary endpoint: Changes in microbial composition. Secondary endpoints: Changes in clinical and immunological parameters
Interventions
BEHAVIORALOral hygiene discontinuation
Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care
Sponsors
Deerland Probiotics and Enzymes
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
\- age \> 18 yrs.
Exclusion criteria
* Presence of oral diseases i.e. gingivitis, periodontitis and dental caries * Current smokers * Any systemic diseases and current use of any medication with known effect on oral health * Use of systemic antibiotics within the latest three months * Age \< 18 yrs., and age \> 30 yrs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in microbial composition in dental | Baseline vs. Day 14 and Day 28 | Changes in alpha and beta diversity of microbial composition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in clinical parameters | Baseline vs. Day 14 and Day 28 | Changes in levels of dental plaque and gingival inflammation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in salivary levels of inflammatory cytokines | Baseline vs. Day 14 and Day 28 | Changes in mean salivary levels of selected inflammatory cytokines |
Countries
Denmark
Outcome results
None listed