About this trial
The goal of this clinical trial is to compare a toothpaste designed for adults aged 50 years and older with a standard toothpaste in orally healthy adults. The main question is whether the 50+ toothpaste reduces bad breath more than the standard toothpaste after 14 days of twice-daily use. The study will also assess tongue coating, dry mouth symptoms, saliva production, oral comfort, oral health-related quality of life, taste, acceptability, and unwanted effects.
About 30 adults aged 18 to 65 years will take part. Each participant will use both toothpastes for 14 days each, in a randomly assigned order, with a 14-day break between the two treatment periods. Neither the participants nor the examiner performing the assessments will know which toothpaste is being used during each period.
At the study visits, bad breath will be measured using a device that detects volatile sulfur compounds in the mouth. Participants will also undergo an examination of the tongue, provide saliva samples, and complete questionnaires. Before each assessment visit, participants will be asked not to perform oral hygiene for 24 hours and to avoid food, drinks other than water, smoking, chewing gum, and oral care products for 3 to 4 hours.
Eligibility criteria
Qualifiers
Age between 18 and 65 years.
Male or female.
Orally healthy according to clinical examination, with no active oral condition that could interfere with study outcomes.
At least 20 natural teeth.
Disqualifiers
Active oral or dental disease that could interfere with the study outcomes. Active periodontitis.
Periodontal probing depths greater than 3 mm at multiple sites, according to clinical judgment.
Clinically relevant generalized gingival bleeding.
Clinically relevant untreated cavitated caries.
Trial design
Treatments tested in this trial
- 50+ Toothpaste
- Standard Fluoride Toothpaste