Oral Malodor (Halitosis)HALI-50PLUSNCT07780474
Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults
A study testing 50+ Toothpaste and Standard Fluoride Toothpaste in people with Oral Malodor (Halitosis) and Oral Dryness, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor (Halitosis), Oral Dryness
- What is being tested?
- 50+ Toothpaste and Standard Fluoride Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
Andrea Scribante, Associate Professor, +39 0382516223, andrea.scribante@unipv.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Malodor (Halitosis), Oral Dryness
- Being tested
- 50+ Toothpaste, Standard Fluoride Toothpaste
- Keywords
- Toothpaste, Oral Malodor, Halitosis, Volatile Sulfur Compounds, Oral Comfort, Dry Mouth, Salivary Flow, Tongue Coating, Sensory Acceptability, Crossover Study
- Medical subject headings
- Halitosis, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50+ ToothpasteOther
Also called Biorepair Advanced Complete Protection 50+ 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.
Standard Fluoride ToothpasteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 50+ Toothpaste Followed by Standard Toothpaste | Experimental | Participants will use the 50+ toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the standard toothpaste twice daily for 14 days. Each brushing session will last 2 minutes. Receives: Other: 50+ Toothpaste; Other: Standard Fluoride Toothpaste |
| Standard Toothpaste Followed by 50+ Toothpaste | Experimental | Participants will use the standard toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the 50+ toothpaste twice daily for 14 days. Each brushing session will last 2 minutes. Receives: Other: 50+ Toothpaste; Other: Standard Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Secondary outcomes (16)
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Participant-Reported Oral Dryness
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Participant-Reported Oral Comfort
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Oral Health Impact Profile-14 Total Score
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.
Measured: Baseline (T0) and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Unstimulated Salivary Flow Rate
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Stimulated Salivary Flow Rate
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.
Measured: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Overall Taste Pleasantness Score
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.
Measured: After 14 days of treatment (T2) in each treatment period
Perceived Freshness Score
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.
Measured: After 14 days of treatment (T2) in each treatment period
Perceived Taste Persistence Score
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.
Measured: After 14 days of treatment (T2) in each treatment period
Unpleasant Aftertaste Score
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.
Measured: After 14 days of treatment (T2) in each treatment period
Willingness to Continue Using the Toothpaste
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.
Measured: After 14 days of treatment (T2) in each treatment period
Participant-Reported Product Attribute Ratings
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.
Measured: After 14 days of treatment (T2) in each treatment period
Incidence of Treatment-Emergent Adverse Events
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.
Measured: From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Malodor (Halitosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780474
- Sponsor's protocol ID
- HALI-50PLUS-2026
- Acronym
- HALI-50PLUS
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07780474
- Acronym / sponsor ID
- HALI-50PLUS / HALI-50PLUS-2026
- Conditions
- Oral Malodor (Halitosis), Oral Dryness
- Keywords
- Toothpaste, Oral Malodor, Halitosis, Volatile Sulfur Compounds, Oral Comfort, Dry Mouth, Salivary Flow, Tongue Coating
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 50+ Toothpaste Followed by Standard Toothpaste | Experimental | Other: 50+ Toothpaste, Other: Standard Fluoride ToothpasteParticipants will use the 50+ toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the standard toothpaste twice daily for 14 days. Each brushing session will last 2 minutes. |
| Standard Toothpaste Followed by 50+ Toothpaste | Experimental | Other: 50+ Toothpaste, Other: Standard Fluoride ToothpasteParticipants will use the standard toothpaste twice daily for 14 days, followed by a 14-day washout period. They will then use the 50+ toothpaste twice daily for 14 days. Each brushing session will last 2 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50+ ToothpasteAlso: Biorepair Advanced Complete Protection 50+ ToothpasteA 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. | Other | 50+ Toothpaste Followed by Standard Toothpaste, Standard Toothpaste Followed by 50+ Toothpaste |
| Standard Fluoride ToothpasteA 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. | Other | 50+ Toothpaste Followed by Standard Toothpaste, Standard Toothpaste Followed by 50+ Toothpaste |
Primary outcome
Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days
Time frame: 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.
16 secondary outcomes
Percentage Change From Baseline in Oral Volatile Sulfur Compound Concentration
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Tongue Coating Severity Score
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Participant-Reported Oral Malodor
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Summated Xerostomia Inventory Score
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Participant-Reported Oral Dryness
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Participant-Reported Oral Comfort
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Oral Health Impact Profile-14 Total Score
Time frame: Baseline (T0) and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Unstimulated Salivary Flow Rate
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Change From Baseline in Stimulated Salivary Flow Rate
Time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
Overall Taste Pleasantness Score
Time frame: After 14 days of treatment (T2) in each treatment period
Perceived Freshness Score
Time frame: After 14 days of treatment (T2) in each treatment period
Perceived Taste Persistence Score
Time frame: After 14 days of treatment (T2) in each treatment period
Unpleasant Aftertaste Score
Time frame: After 14 days of treatment (T2) in each treatment period
Willingness to Continue Using the Toothpaste
Time frame: After 14 days of treatment (T2) in each treatment period
Participant-Reported Product Attribute Ratings
Time frame: After 14 days of treatment (T2) in each treatment period
Incidence of Treatment-Emergent Adverse Events
Time frame: From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
Related trials for Oral Malodor (Halitosis)
Recruiting
The Additional Effect of Tongue Scraping on Halitosis Parameters in Initial Periodontal Therapy
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Enrolling by invitation
Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath
Halitosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Scribante principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50+ Toothpaste and Standard Fluoride Toothpaste in people with Oral Malodor (Halitosis) and Oral Dryness, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Scribante, Associate Professor (+39 0382516223, andrea.scribante@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days (time frame: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.