Effects of a 50+ Toothpaste on Halitosis and Oral Comfort in Healthy Adults (HALI-50PLUS)
18 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Stato
Non ancora reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
30
Fase
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Andrea Scribante, Associate Professor
- Numero di telefono: +39 0382516223
- Email: andrea.scribante@unipv.it
Luoghi di studio
-
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Lombardy
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Pavia, Lombardy, Italia, 27100
- Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
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Contatto:
- Andrea Scribante, Associate Professor
- Numero di telefono: +39 0382516223
- Email: andrea.scribante@unipv.it
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
Altri nomi:
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.
|
|
Sperimentale: 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.
|
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.
Altri nomi:
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days
Lasso di tempo: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage Change From Baseline in Oral Volatile Sulfur Compound Concentration
Lasso di tempo: 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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Tongue Coating Severity Score
Lasso di tempo: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Participant-Reported Oral Malodor
Lasso di tempo: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
|
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Change From Baseline in Summated Xerostomia Inventory Score
Lasso di tempo: 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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Participant-Reported Oral Dryness
Lasso di tempo: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Participant-Reported Oral Comfort
Lasso di tempo: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Oral Health Impact Profile-14 Total Score
Lasso di tempo: 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.
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Baseline (T0) and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Unstimulated Salivary Flow Rate
Lasso di tempo: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Change From Baseline in Stimulated Salivary Flow Rate
Lasso di tempo: Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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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.
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Baseline (T0), after 7 days of treatment (T1), and after 14 days of treatment (T2) in each treatment period
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Overall Taste Pleasantness Score
Lasso di tempo: After 14 days of treatment (T2) in each treatment period
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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.
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After 14 days of treatment (T2) in each treatment period
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Perceived Freshness Score
Lasso di tempo: After 14 days of treatment (T2) in each treatment period
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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.
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After 14 days of treatment (T2) in each treatment period
|
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Perceived Taste Persistence Score
Lasso di tempo: After 14 days of treatment (T2) in each treatment period
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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.
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After 14 days of treatment (T2) in each treatment period
|
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Unpleasant Aftertaste Score
Lasso di tempo: After 14 days of treatment (T2) in each treatment period
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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.
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After 14 days of treatment (T2) in each treatment period
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Willingness to Continue Using the Toothpaste
Lasso di tempo: 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.
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After 14 days of treatment (T2) in each treatment period
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Participant-Reported Product Attribute Ratings
Lasso di tempo: After 14 days of treatment (T2) in each treatment period
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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.
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After 14 days of treatment (T2) in each treatment period
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Incidence of Treatment-Emergent Adverse Events
Lasso di tempo: From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks
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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.
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From the first product administration at T0 through the final assessment at T2 of the second treatment period, approximately 6 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Andrea Scribante, University of Pavia
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
Inizio studio
1 ottobre 2026
Completamento primario (Stimato)
Completamento primario
1 dicembre 2026
Completamento dello studio (Stimato)
Completamento dello studio
15 dicembre 2026
Date di iscrizione allo studio
Primo inviato
Primo inviato
18 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2026
Primo Inserito (Effettivo)
Primo Inserito
21 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
21 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 agosto 2026
Ultimo verificato
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- HALI-50PLUS-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Data will be available upon motivated request to the corresponding authors.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .