Oral Dryness, Oral Malodor (Halitosis)
Conditions
Keywords
Toothpaste, Oral Malodor, Halitosis, Volatile Sulfur Compounds, Oral Comfort, Dry Mouth, Salivary Flow, Tongue Coating, Sensory Acceptability, Crossover Study
Brief summary
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.
Detailed description
This study will evaluate whether a toothpaste formulated for adults aged 50 years and older provides greater control of oral malodor and improved oral comfort compared with a standard commercially available fluoride toothpaste. Oral malodor will be assessed under standardized conditions using a reversible physiological model based on the temporary suspension of oral hygiene. No chemical substance will be used to induce malodor. The study will use a randomized crossover design. Each participant will receive both study products in a randomly assigned sequence. Each treatment period will last 14 days and will be separated by a 14-day washout period, during which participants will return to their usual oral hygiene routine while avoiding products specifically intended for halitosis or dry mouth. Participants will brush twice daily for 2 minutes using only the assigned toothpaste. Tongue brushing and the use of mouthwashes or other products that could affect oral malodor or dry mouth will not be permitted during the treatment periods. The test and control toothpastes will be supplied in neutral, indistinguishable packaging. Participants and the examiner responsible for the clinical and instrumental assessments will remain unaware of product identity. The treatment codes will be disclosed only after the study database has been finalized, unless disclosure is required for participant safety. Assessments will be performed at baseline and after 7 and 14 days of each treatment period. Before each assessment, participants will suspend oral hygiene for 24 hours and follow standardized restrictions concerning food, beverages, smoking, chewing gum, and oral care products. This approach is intended to reduce measurement variability and allow each participant to serve as their own control.
Interventions
OTHER50+ Toothpaste
A 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.
A 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.
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The statistician will remain masked to treatment identity and will analyze the products using coded labels. Both toothpastes will be provided in neutral, indistinguishable packaging. The randomization list and the link between product codes and treatment identity will be held by designated personnel who are not involved in outcome assessment or statistical analysis. Treatment codes will be disclosed only after database lock, unless unmasking is required for participant safety.
Intervention model description
Participants will receive both study products in a randomized two-treatment, two-period, two-sequence crossover design. Sequence A will receive the 50+ toothpaste followed by the standard toothpaste, while Sequence B will receive the products in the reverse order. Each treatment period will last 14 days, with a 14-day washout period between treatments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Oral Volatile Sulfur Compound Concentration | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | 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. |
| Change From Baseline in Tongue Coating Severity Score | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | 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. |
| Change From Baseline in Participant-Reported Oral Malodor | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | 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. |
| Change From Baseline in Summated Xerostomia Inventory Score | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | 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. |
| Change From Baseline in Participant-Reported Oral Dryness | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | Participants will rate their perceived oral dryness using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no oral dryness and 10 indicates the greatest possible oral dryness. Lower scores indicate improvement. |
| Change From Baseline in Participant-Reported Oral Comfort | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | Participants will rate their overall oral comfort using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no oral comfort and 10 indicates the greatest possible oral comfort. Higher scores indicate better perceived oral comfort. |
| Change From Baseline in Oral Health Impact Profile-14 Total Score | Baseline (T0) and after 14 days of treatment (T2) in each treatment period | Oral health-related quality of life will be assessed using the 14-item Oral Health Impact Profile. Each item is scored from 0, never, to 4, very often. The scores are summed to obtain a total score ranging from 0 to 56. Higher scores indicate a greater negative impact of oral health on quality of life. |
| Change From Baseline in Unstimulated Salivary Flow Rate | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | Unstimulated whole saliva will be collected for 5 minutes using the spitting method. The total collected volume will be divided by the collection duration and expressed in milliliters per minute (mL/min). Higher values indicate a greater unstimulated salivary flow rate. |
| Change From Baseline in Stimulated Salivary Flow Rate | Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period | Stimulated whole saliva will be collected for 5 minutes using the spitting method after standardized gustatory stimulation with citric acid. The total collected volume will be divided by the collection duration and expressed in milliliters per minute (mL/min). Higher values indicate a greater stimulated salivary flow rate. |
| Overall Taste Pleasantness Score | After 14 days of treatment (T2) in each treatment period | Participants will rate the overall pleasantness of the toothpaste taste using a 9-point hedonic scale ranging from 1, extremely unpleasant, to 9, extremely pleasant. Higher scores indicate greater taste pleasantness. |
| Perceived Freshness Score | After 14 days of treatment (T2) in each treatment period | Participants will rate the freshness perceived after brushing using an 11-point numerical rating scale ranging from 0, no perceived freshness, to 10, maximum perceived freshness. Higher scores indicate greater perceived freshness. |
| Perceived Taste Persistence Score | After 14 days of treatment (T2) in each treatment period | Participants will rate the persistence of the toothpaste taste after brushing using an 11-point numerical rating scale ranging from 0, not persistent at all, to 10, extremely persistent. Higher scores indicate greater perceived taste persistence. |
| Unpleasant Aftertaste Score | After 14 days of treatment (T2) in each treatment period | Participants will rate unpleasant aftertaste using an 11-point numerical rating scale ranging from 0, no unpleasant aftertaste, to 10, extremely unpleasant aftertaste. Lower scores indicate better sensory acceptability. |
| Willingness to Continue Using the Toothpaste | After 14 days of treatment (T2) in each treatment period | Participants will rate their willingness to continue using the assigned toothpaste using an 11-point numerical rating scale ranging from 0, not willing at all, to 10, completely willing to continue its use. Higher scores indicate greater willingness to continue using the product. |
| Participant-Reported Product Attribute Ratings | After 14 days of treatment (T2) in each treatment period | Participants will separately rate product odor, color, consistency, sensation of cleanliness, perceived effect on breath, perceived effect on oral dryness, lubricating effect, moisturizing effect, and willingness to reuse the product. Each attribute will be rated using an 11-point numerical rating scale from 0 to 10 and analyzed separately without calculating a combined total score. Higher scores indicate a more favorable assessment of each product attribute. |
| Incidence of Treatment-Emergent Adverse Events | From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks | The number and percentage of participants experiencing treatment-emergent adverse events will be recorded for each toothpaste. Events of interest include oral burning, mucosal irritation, ulceration, taste alteration, nausea, increased oral dryness, hypersalivation, pain, and oral discomfort. Each event will be classified according to intensity, seriousness, duration, relationship to the study product, and action taken. |
Countries
Italy
Contacts
CONTACTAndrea Scribante, Associate Professor
PRINCIPAL_INVESTIGATORAndrea Scribante
University of Pavia
Outcome results
None listed