Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Pavia
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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
50+ Toothpaste
Other interventionA toothpaste formulated for adults aged 50 years and older. Participants will use approximately 2 cm of toothpaste to brush their teeth for 2 minutes, twice daily, for 14 consecutive days. The product will be supplied in neutral, coded packaging to maintain masking. Participants will not use other toothpastes, mouthwashes, tongue-cleaning procedures, or products intended for halitosis or dry mouth during the treatment period.
Standard Fluoride Toothpaste
Other interventionA commercially available fluoride toothpaste intended for routine oral hygiene, without specific claims for halitosis or dry mouth and without ingredients specifically intended to neutralize volatile sulfur compounds. Participants will use approximately 2 cm of toothpaste to brush their teeth for 2 minutes, twice daily, for 14 consecutive days. The product will be supplied in neutral, coded packaging, and the same oral hygiene restrictions used for the 50+ toothpaste will apply.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: 50+ Toothpaste Followed by Standard ToothpasteExperimental treatment 2 interventions
Group B: Standard Toothpaste Followed by 50+ ToothpasteExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days
Oral volatile sulfur compound concentration will be measured using a Halimeter Plus and expressed in parts per billion (ppb). At each assessment, three valid consecutive measurements will be obtained, and their mean will be used for analysis. For each treatment period, change from baseline will be calculated as the value after 14 days minus the baseline value. Lower values and greater reductions indicate improvement in oral malodor. The primary comparison will assess the within-participant difference in change between the 50+ toothpaste and the standard fluoride toothpaste.
Time frame
Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment periodSecondary outcomes
1
Percentage Change From Baseline in Oral Volatile Sulfur Compound Concentration
Oral volatile sulfur compound concentration will be measured using a Halimeter Plus and expressed in parts per billion (ppb). The percentage reduction will be calculated as: \[(baseline value - follow-up value) / baseline value\] × 100. A higher positive percentage indicates a greater reduction in oral malodor. Percentage changes obtained with the 50+ toothpaste and the standard fluoride toothpaste will be compared within participants.
Time frame
Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period2
Change From Baseline in Tongue Coating Severity Score
Tongue coating will be assessed clinically using a 4-point severity score: 0, no visible coating; 1, thin coating with the underlying mucosal color visible; 2, moderate coating; and 3, thick coating with marked mucosal coverage. Lower scores indicate less tongue coating. The predominant location of the coating will also be recorded as anterior, middle, posterior, or diffuse.
Time frame
Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period3
Change From Baseline in Participant-Reported Oral Malodor
Participants will rate their perceived oral malodor using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no perceived bad breath and 10 indicates the worst perceived bad breath. Lower scores indicate improvement.
Time frame
Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period4
Change From Baseline in Summated Xerostomia Inventory Score
Subjective dry mouth symptoms will be assessed using the 5-item Summated Xerostomia Inventory. Each item is scored from 1, never, to 5, almost always. The item scores are summed to produce a total score ranging from 5 to 25. Higher scores indicate more severe subjective dry mouth symptoms.
Time frame
Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment periodSponsors and contacts
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Source ClinicalTrials.gov
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