The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.
The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
24
Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.
Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.
Aarhus University
Aarhus C, Denmark
Accumulation of dental plaque after 24 hours
Dental plaque assessed by the modified Quigley-Hein Plaque Index
Time frame: Change in dental plaque score from baseline to 24 hours' follow-up
Accumulation of dental plaque after 7 days
Dental plaque assessed by the modified Quigley-Hein Plaque Index
Time frame: Change in dental plaque score from baseline to 7 days' follow-up
Development of gingivitis after 7 days
Gingivitis assessed by the Silness-Löe Plaque Index
Time frame: Change in gingivitis score from baseline to 7 days' follow-up
Microbial characterization of the oral microbiome from plaque and saliva samples
Assessed by 16S rRNA sequencing
Time frame: 7 days' follow-up
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