Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults

Clinical, Instrumental, and Subjective Evaluation of the Anti-Halitosis Efficacy, Effects on Oral Comfort, and Sensory Acceptability of a 50+ Toothpaste Compared With a Standard Toothpaste in Orally Healthy Adults: A Randomized, Controlled, Double-Blind, Crossover Clinical 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.

Inclusion Criteria:

• 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.
• No active periodontitis.
• No clinically relevant untreated cavitated caries.
• No acute oral mucosal disease.
• Any existing systemic condition must be stable, controlled, and considered unlikely to interfere with the study outcomes.
• Willingness to use only the oral care products provided during each treatment period.
• Willingness to refrain from oral hygiene procedures for 24 hours before each assessment visit.
• Willingness to refrain from food, beverages other than water, smoking, chewing gum, candies, oral sprays, mouthwashes, and oral hygiene procedures for 3 to 4 hours before each assessment.
• Ability to understand the study objectives and procedures.
• Provision of written informed consent.

Exclusion Criteria:

• 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.
• Oral candidiasis.
• Oral ulceration, stomatitis, symptomatic oral mucosal lesions, or acute oral infection.
• Clinical signs of severe xerostomia or pathological hyposalivation.
• Fewer than 20 natural teeth.
• Acute systemic disease or uncontrolled chronic systemic disease. Uncontrolled diabetes mellitus.
• Active autoimmune or systemic inflammatory disease.
• Gastrointestinal, respiratory, otorhinolaryngological, or metabolic conditions associated with clinically significant extraoral halitosis.
• Use of systemic antibiotics within 4 weeks before enrollment.
• Habitual use of antiseptic mouthwashes, anti-halitosis products, or dry-mouth products within 2 weeks before enrollment.
• Use of medications with a strong xerostomic effect that, in the investigator's judgment, could interfere with study outcomes.
• Smoking more than 10 cigarettes per day.
• Inability to refrain from smoking for 3 to 4 hours before assessment visits.
• Pregnancy or breastfeeding.
• Known or suspected allergy to any component of the study products.
• Professional dental cleaning or invasive dental procedures within 2 weeks before enrollment.
• Inability or unwillingness to comply with the study procedures.
• Participation in another clinical study within 4 weeks before enrollment.