Dental Plaque, Gingivitis, Microbial Colonization
Conditions
Brief summary
The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTEnzyme containing lozenge
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.
DIETARY_SUPPLEMENTPlacebo lozenge
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.
Sponsors
University of Aarhus
Novozymes A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy males and females ≥18 years of age. * Able to read, sign and receive a copy of the signed informed consent form. * Have at least 20 natural teeth.
Exclusion criteria
* Clinically visible active caries lesions and/or periodontitis. * Significant oral soft tissue pathology based on a visual examination. * History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients. * History of allergies to ingredients in the test product. * History of allergies towards enzymes. * Self-reported as pregnant or nursing. * Self-reported serious medical conditions. * Antibiotic or anti-inflammatory medication within 30 days of screening visit. * Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures. * Acute sinusitis or severe oral-pharyngeal infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accumulation of dental plaque after 24 hours | Change in dental plaque score from baseline to 24 hours' follow-up | Dental plaque assessed by the modified Quigley-Hein Plaque Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of gingivitis after 7 days | Change in gingivitis score from baseline to 7 days' follow-up | Gingivitis assessed by the Silness-Löe Plaque Index |
| Accumulation of dental plaque after 7 days | Change in dental plaque score from baseline to 7 days' follow-up | Dental plaque assessed by the modified Quigley-Hein Plaque Index |
| Microbial characterization of the oral microbiome from plaque and saliva samples | 7 days' follow-up | Assessed by 16S rRNA sequencing |
Countries
Denmark
Outcome results
None listed