Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults (HALI-50PLUS)

August 18, 2026 updated by: Andrea Scribante, University of Pavia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 50+ Toothpaste Followed by Standard Toothpaste
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.
Other: 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.
Other Names:
  • Biorepair Advanced Complete Protection 50+ Toothpaste
Other: Standard Fluoride Toothpaste
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.
Experimental: Standard Toothpaste Followed by 50+ Toothpaste
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.
Other: 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.
Other Names:
  • Biorepair Advanced Complete Protection 50+ Toothpaste
Other: Standard Fluoride Toothpaste
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pavia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea Scribante, University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HALI-50PLUS-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon motivated request to the corresponding authors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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