Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

18. august 2026 oppdatert av: 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.

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Har ikke rekruttert ennå

Forhold

Forhold

Sykdommen, lidelsen, syndromet, sykdommen eller skaden som studeres. På ClinicalTrials.gov kan tilstander også inkludere andre helserelaterte problemer, som levetid, livskvalitet og helserisiko.

Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.

Detaljert beskrivelse

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.

Studietype

Studietype

Beskriver arten av en klinisk studie. Studietyper inkluderer intervensjonsstudier (også kalt kliniske studier), observasjonsstudier (inkludert pasientregistre) og utvidet tilgang.
Intervensjonell

Registrering (Antatt)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
30

Fase

Fase

Stadiet av en klinisk studie som studerer et medikament eller biologisk produkt, basert på definisjoner utviklet av U.S. Food and Drug Administration (FDA). Fasen er basert på studiens målsetting, antall deltakere og andre egenskaper. Det er fem faser: Tidlig fase 1 (tidligere oppført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant brukes til å beskrive studier uten FDA-definerte faser, inkludert utprøving av enheter eller atferdsintervensjoner.
  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiekontakt

Navn og kontaktinformasjon for personen som kan svare på påmeldingsspørsmål for en klinisk studie. Hvert sted hvor studien gjennomføres kan også ha en spesifikk kontakt, som kan være bedre i stand til å svare på disse spørsmålene.

Studiesteder

  • Italia
    • Lombardy
      • Pavia, Lombardy, Italia, 27100
        • Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Kvalifikasjonskriterier

Nøkkelkravene som personer som ønsker å delta i en klinisk studie må oppfylle eller egenskapene de må ha. Kvalifikasjonskriterier består av både inklusjonskriterier (som kreves for at en person skal delta i studien) og eksklusjonskriterier (som hindrer en person i å delta). Typer kvalifikasjonskriterier inkluderer om en studie godtar friske frivillige, har alders- eller aldersgruppekrav, eller er begrenset av kjønn.

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm

Deltakergruppe / Arm

En gruppe eller undergruppe av deltakere i en klinisk studie som mottar en spesifikk intervensjon/behandling, eller ingen intervensjon, i henhold til studiens protokoll.
Intervensjon / Behandling

Intervensjon / Behandling

En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Eksperimentell: 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.
Annen: 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.
Andre navn:
  • Biorepair Advanced Complete Protection 50+ Toothpaste
Annen: 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.
Eksperimentell: 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.
Annen: 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.
Andre navn:
  • Biorepair Advanced Complete Protection 50+ Toothpaste
Annen: 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.

Hva måler studien?

Primære resultatmål

Primære resultatmål

I en klinisk studies protokoll er det planlagte utfallsmålet som er det viktigste for å evaluere effekten av en intervensjon/behandling. De fleste kliniske studier har ett primært utfallsmål, men noen har mer enn ett.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Oral Volatile Sulfur Compound Concentration After 14 Days
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk studies protokoll, et planlagt utfallsmål som ikke er like viktig som det primære utfallsmålet for å evaluere effekten av en intervensjon, men som fortsatt er av interesse. De fleste kliniske studier har mer enn ett sekundært utfallsmål.
Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage Change From Baseline in Oral Volatile Sulfur Compound Concentration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sponsor

Organisasjonen eller personen som initierer studien og som har myndighet og kontroll over studien.
University of Pavia

Etterforskere

Etterforskere

En forsker involvert i en klinisk studie. Beslektede termer inkluderer stedets hovedetterforsker, stedsunderetterforsker, studieleder, studieleder og studiehovedetterforsker.
  • Hovedetterforsker: Andrea Scribante, University of Pavia

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

Studiestart

Den faktiske datoen da den første deltakeren ble registrert i en klinisk studie. Den "forventede" studiestartdatoen er datoen som forskerne tror vil være studiestartdatoen.
1. oktober 2026

Primær fullføring (Antatt)

Primær fullføring

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon for å samle inn endelige data for det primære utfallsmålet. Hvorvidt den kliniske studien ble avsluttet i henhold til protokollen eller ble avsluttet, påvirker ikke denne datoen. For kliniske studier med mer enn ett primært utfallsmål med ulike fullføringsdatoer, refererer dette begrepet til datoen da datainnsamlingen er fullført for alle de primære utfallsmålene. Den "forventede" primære fullføringsdatoen er datoen som forskerne tror vil være den primære fullføringsdatoen for studien.
1. desember 2026

Studiet fullført (Antatt)

Studiet fullført

Datoen da den siste deltakeren i en klinisk studie ble undersøkt eller mottok en intervensjon/behandling for å samle inn endelige data for de primære utfallsmålene, sekundære utfallsmålene og uønskede hendelsene (det vil si siste deltakers siste besøk). Den "forventede" studiens fullføringsdato er datoen som forskerne tror vil være studiens fullføringsdato.
15. desember 2026

Datoer for studieregistrering

Først innsendt

Først innsendt

Datoen da studiesponsoren eller etterforskeren først sendte inn en studiepost til ClinicalTrials.gov. Det er vanligvis en forsinkelse på noen dager mellom første innsendte dato og postens tilgjengelighet på ClinicalTrials.gov (den første postedatoen).
18. august 2026

Først innsendt som oppfylte QC-kriteriene

Først innsendt som oppfylte QC-kriteriene

Datoen da studiesponsoren eller etterforskeren først sender inn en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Sponsoren eller etterforskeren må kanskje revidere og sende inn en studiepost én eller flere ganger før NLMs kvalitetskontrollkriterier oppfylles. Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
18. august 2026

Først lagt ut (Faktiske)

Først lagt ut

Datoen da studieposten først var tilgjengelig på ClinicalTrials.gov etter at National Library of Medicine (NLM) kvalitetskontroll (QC) gjennomgang har konkludert. Det er vanligvis en forsinkelse på noen dager mellom datoen studiesponsoren eller etterforskeren sendte inn studieposten og den første postedatoen.
21. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Sist oppdatering lagt ut

Den siste datoen da endringer i en studiepost ble gjort tilgjengelig på ClinicalTrials.gov. Det kan være en forsinkelse mellom når endringene ble sendt til ClinicalTrials.gov av studiens sponsor eller etterforsker (datoen for siste innsending av oppdatering) og datoen for siste oppdatering.
21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Den siste datoen da studiesponsoren eller etterforskeren sendte inn endringer i en studiepost som er i samsvar med gjennomgangskriteriene for National Library of Medicine (NLM) kvalitetskontroll (QC). Det er sponsorens eller etterforskerens ansvar å sikre at studieposten er i samsvar med NLM QC-gjennomgangskriteriene.
18. august 2026

Sist bekreftet

Sist bekreftet

Den siste datoen da studiesponsoren eller etterforskeren bekreftet at informasjonen om en klinisk studie på ClinicalTrials.gov var nøyaktig og oppdatert. Hvis en studie med rekrutteringsstatus for rekruttering; ikke rekrutterer ennå; eller aktiv, ikke rekruttering har ikke blitt bekreftet de siste 2 årene, studiens rekrutteringsstatus vises som ukjent.
1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Andre studie-ID-numre

Identifikatorer eller ID-numre andre enn NCT-nummeret som er tildelt en klinisk studie av studiens sponsor, finansierere eller andre. Disse tallene kan inkludere unike identifikatorer fra andre prøveregistre og National Institutes of Health-stipendnumre.
  • HALI-50PLUS-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Innstillinger for informasjonskapsler

Vi bruker informasjonskapsler for å sikre at vi gir deg den beste opplevelsen på nettstedet vårt. For mer informasjon, les nøye vår Retningslinjer for personvern og informasjonskapsler. ...>>>Du kan når som helst endre preferansene dine eller trekke tilbake samtykket ditt ved å slette informasjonskapslene fra nettstedet ditt eller datamaskinen som beskrevet i policyen. Godta det og velg dine preferanser ved å krysse av i de tilhørende rutene i delen "Administrer innstillinger" nedenfor. Les nøye gjennom servicevilkårene før du fortsetter å bruke noen del av dette nettstedet.
«Administrer innstillinger