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Uno studio clinico per valutare la sicurezza e l'efficacia anti-carie dei dentifrici senza fluoro COL 101 (arginina) rispetto al controllo del dentifricio con fluoruro di sodio allo 0,24% (1100 ppm F) nei bambini di età compresa tra 10 e 14 anni

20 luglio 2026 aggiornato da: Colgate Palmolive

Uno studio clinico multicentrico di fase 2 randomizzato, in doppio cieco, con controllo attivo per valutare la sicurezza e l'efficacia anti-carie dei dentifrici COL 101 (arginina) senza fluoro con 1,5%, 4,0% e 8,0% di arginina ciascuno a confronto Con lo 0,24% di fluoruro di sodio (1100 ppm F) controllo dentifricio nei bambini di età compresa tra 10 e 14 anni

L'obiettivo di questo studio è valutare la sicurezza e valutare l'efficacia anti-carie dei dentifrici senza fluoro COL101 (arginina) rispetto a un dentifricio al fluoruro di sodio allo 0,24% in bambini di 10-14 anni per un periodo di un anno.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

In this phase 2, double-blind, randomized, active-controlled multi-center study, 2025 subjects were randomized in a ratio of 1:1:1:1 into one of four parallel study groups (1.5% arginine dentifrice, 4.0% arginine dentifrice, 8.0% arginine dentifrice or 0.24% NaF dentifrice with no arginine). Subjects were asked to brush their teeth twice daily at home (unsupervised use) with the assigned dentifrice for a duration of 1 year. Measurements for efficacy, safety and assessment of product use compliance were conducted at baseline, 6 months (±1 month) and 1 year (±1 month). Additional safety evaluations including evaluation of oral soft and hard tissues, as well as product use compliance assessment was performed at 3 months and 9 months (±1 month). All subjects were monitored for adverse events (AEs) during the course of the study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2025

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Porto Rico
      • San Juan, Porto Rico
        • University of Puerto Rico School of Dental Medicine
  • Stati Uniti
    • California
      • Loma Linda, California, Stati Uniti, 92350
        • Loma Linda University School of Dentistry
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • University of Florida College of Dentistry
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202-2876
        • Indiana University School of Dentistry
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
        • Tufts University School of Dental Medicine
      • Boston, Massachusetts, Stati Uniti, 02142
        • The Forsyth Institute
    • New York
      • Buffalo, New York, Stati Uniti, 14214
        • University at Buffalo School of Dental Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104-6003
        • University of Pennsylvania School of Dental Medicine
    • Texas
      • San Antonio, Texas, Stati Uniti, 78229-3900
        • UT Health San Antonio School of Dentistry

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

Età idonea allo studio

Da 10 anni a 14 anni (Bambino)

Accetta volontari sani

Sì

Descrizione

Criterio di inclusione:

  • I soggetti che soddisfano tutti i criteri di seguito saranno inclusi nello studio:

    1. Consenso del soggetto e consenso informato del genitore/tutore per la partecipazione volontaria.
    2. Disponibilità e capacità di utilizzare i prodotti assegnati secondo le istruzioni, disponibilità per tutti gli appuntamenti e probabilità di completare la sperimentazione clinica.
    3. Bambini di età compresa tra 10 e 14 anni al basale.
    4. Presenza di secondi molari permanenti o evidenza di almeno un secondo molare permanente in eruzione come indicato dalla rottura delle cuspidi attraverso la mucosa.
    5. Buona salute generale come evidenziato da una revisione della storia medica.
    6. Soggetti che, all'ingresso nello studio, presentano due o più lesioni cariose attive (punteggio ICDAS pari o superiore a 2) nei denti permanenti e precedente esperienza di carie (DMFT >1), D= Carie è definito come punteggio ICDAS pari o superiore a 3

Criteri di esclusione:

  • I soggetti che presentano uno qualsiasi dei seguenti criteri saranno esclusi dallo studio:

    1. Presenza di apparecchio protesico fisso o rimovibile o trattamento ortodontico che coinvolga più di quattro denti permanenti.

    2. Uso di farmaci che potrebbero aumentare il rischio di sviluppare la carie dentale, ad es.

      farmaci che riducono il flusso di saliva e quelli ad alto contenuto di zucchero.

    3. Terapia antibiotica a lungo termine.
    4. Bambini con diagnosi confermata di compromissione cognitiva e/o motoria.
    5. Grave malocclusione.
    6. - Soggetti che, all'ingresso nello studio, presentano carie grave (ICDAS 5 o 6) su cinque o più denti permanenti.
    7. Evidenza di malattia parodontale da moderata a grave.
    8. Partecipazione a qualsiasi altro studio clinico entro i 30 giorni precedenti l'inizio dello studio clinico.
    9. Storia nota di allergie o altre reazioni avverse all'arginina o ai prodotti per l'igiene orale o ai loro ingredienti.
    10. Anamnesi autodichiarata di gravidanza in corso, intenzione di rimanere incinta durante il periodo di prova o allattamento.

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 parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Dentifricio al fluoruro di sodio allo 0,24%.
Dentifricio
Droga: Dentifricio al fluoruro di sodio allo 0,24%.
Spazzolare tutta la bocca con un dentifricio, 2 volte al giorno per 2 minuti ogni volta per tutta la durata dello studio
Sperimentale: Dentifricio di arginina all'1,5%.
Dentifricio
Droga: Dentifricio di arginina all'1,5%.
Spazzolare tutta la bocca con un dentifricio, 2 volte al giorno per 2 minuti ogni volta per tutta la durata dello studio
Sperimentale: Dentifricio di arginina al 4,0%.
Dentifricio
Droga: Dentifricio di arginina al 4,0%.
Spazzolare tutta la bocca con un dentifricio, 2 volte al giorno per 2 minuti ogni volta per tutta la durata dello studio
Sperimentale: Dentifricio di arginina all'8,0%.
Dentifricio
Droga: Dentifricio di arginina all'8,0%.
Spazzolare tutta la bocca con un dentifricio, 2 volte al giorno per 2 minuti ogni volta per tutta la durata dello studio

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
Lasso di tempo: Between the Baseline and the Month 12 visits
The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations performed at specified time points, calculated by subtraction.
Between the Baseline and the Month 12 visits

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
Lasso di tempo: Between the Baseline and the Month 6 visits
The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations performed at specified time points, calculated by subtraction.
Between the Baseline and the Month 6 visits
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Month 6 and Month 12 Visits
Lasso di tempo: Between the Month 6 and the Month 12 visits
The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations performed at specified time points, calculated by subtraction.
Between the Month 6 and the Month 12 visits
Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 6 Visits
Lasso di tempo: Between the Baseline and the Month 6 visits
The Decayed Missing or Filled Teeth (DMFT) score is a measure of the extent of dental caries for a subject, defined as the number of the up to 28 examined teeth in the subject's mouth on which the examiner determined at least one surface to be decayed, missing, or filled. This score can range between 0 and 28, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFT is defined as the change in DMFT score between two examinations performed at specified time points, calculated by subtraction.
Between the Baseline and the Month 6 visits
Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 12 Visits
Lasso di tempo: Between the Baseline and the Month 12 visits
The Decayed Missing or Filled Teeth (DMFT) score is a measure of the extent of dental caries for a subject, defined as the number of the up to 28 examined teeth in the subject's mouth on which the examiner determined at least one surface to be decayed, missing, or filled. This score can range between 0 and 28, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFT is defined as the change in DMFT score between two examinations performed at specified time points calculated by subtraction.
Between the Baseline and the Month 12 visits
Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Month 6 and the Month 12 Visits
Lasso di tempo: Between the Month 6 and the Month 12 visits
The Decayed Missing or Filled Teeth (DMFT) score is a measure of the extent of dental caries for a subject, defined as the number of the up to 28 examined teeth in the subject's mouth on which the examiner determined at least one surface to be decayed, missing, or filled. This score can range between 0 and 28, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFT is defined as the change in DMFT score between two examinations performed at specified time points, calculated by subtraction.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 6 Visits
Lasso di tempo: Between the Baseline and the Month 6 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 2 or higher; from a score of 1 or 2 to a score of 3 or higher; or from a score of 3 or 4 to a score of 5 or 6. Surfaces with scores between 0 and 4 at the earlier examination are defined as being at risk for caries severity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries progression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 12 Visits
Lasso di tempo: Between the Baseline and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 2 or higher; from a score of 1 or 2 to a score of 3 or higher; or from a score of 3 or 4 to a score of 5 or 6. Surfaces with scores between 0 and 4 at the earlier examination are defined as being at risk for caries severity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries progression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Month 6 and the Month 12 Visits
Lasso di tempo: Between the Month 6 and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 2 or higher; from a score of 1 or 2 to a score of 3 or higher; or from a score of 3 or 4 to a score of 5 or 6. Surfaces with scores between 0 and 4 at the earlier examination are defined as being at risk for caries severity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries progression was calculated.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Severity Score Regressions Between the Baseline and the Month 6 Visits
Lasso di tempo: Between the Baseline and the Month 6 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score severity score regression on a tooth surface is defined as an improvement from a score of 2 or higher to a score of 0 or 1. Tooth surfaces for which the earlier score was between 2 and 6 are defined as being at risk for caries severity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries regression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Severity Score Regressions Between the Baseline and the Month 12 Visits
Lasso di tempo: Between the Baseline and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score severity score regression on a tooth surface is defined as an improvement from a score of 2 or higher to a score of 0 or 1. Tooth surfaces for which the earlier score was between 2 and 6 are defined as being at risk for caries severity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries regression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Severity Score Regressions Between the Month 6 and the Month 12 Visits
Lasso di tempo: Between the Month 6 and the Month 12 visits
The ICDAS caries severity score is a parameter that reports the level of dental caries on each tooth surface using a 7-point ordinal scale ranging from 0 to 6, where higher scores are worse. When considering the time frame between two specified examinations, a clinically significant score severity score regression on a tooth surface is defined as an improvement from a score of 2 or higher to a score of 0 or 1. Tooth surfaces for which the earlier score was between 2 and 6 are defined as being at risk for caries severity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries severity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries regression was calculated.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Baseline and the Month 6 Visits
Lasso di tempo: Between the Baseline and the Month 6 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 1. Surfaces with a score of 0 at the earlier examination are defined as being at risk for caries activity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity progression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Baseline and the Month 12 Visits
Lasso di tempo: Between the Baseline and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 1. Surfaces with a score of 0 at the earlier examination are defined as being at risk for caries activity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity progression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Month 6 and the Month 12 Visits
Lasso di tempo: Between the Month 6 and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score progression is defined as a worsening from a score of 0 to a score of 1. Surfaces with a score of 0 at the earlier examination are defined as being at risk for caries activity progression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity progression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity progression was calculated.
Between the Month 6 and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Baseline and the Month 6 Visits
Lasso di tempo: Between the Baseline and the Month 6 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score regression is defined as an improvement from a score of 1 to a score of 0. Surfaces with a score of 1 at the earlier examination are defined as being at risk for caries activity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity regression was calculated.
Between the Baseline and the Month 6 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Baseline and the Month 12 Visits
Lasso di tempo: Between the Baseline and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score regression is defined as an improvement from a score of 1 to a score of 0. Surfaces with a score of 1 at the earlier examination are defined as being at risk for caries activity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity regression was calculated.
Between the Baseline and the Month 12 visits
Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Month 6 and the Month 12 Visits
Lasso di tempo: Between the Month 6 and the Month 12 visits
The ICDAS caries activity score is a parameter that reports the presence of active dental caries on a tooth surface utilizing a binary categorical scale of 0 (no active caries present) or 1 (active caries present). A score of 0 is the more favorable outcome. When considering the time frame between two specified examinations, a clinically significant score regression is defined as an improvement from a score of 1 to a score of 0. Surfaces with a score of 1 at the earlier examination are defined as being at risk for caries activity regression. For each subject, the number of at-risk tooth surfaces was recorded, as well as the number of those at-risk surfaces that presented a clinically significant caries activity regression between the two examinations. For each treatment group, the mean of the subject-wise percentages of at-risk surfaces exhibiting a clinically significant caries activity regression was calculated
Between the Month 6 and the Month 12 visits

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Colgate Palmolive

Investigatori

  • Direttore dello studio: Maria E Ryan, DDS PhD, Colgate-Palmolive Company

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 (Effettivo)

21 gennaio 2021

Completamento primario (Effettivo)

28 febbraio 2024

Completamento dello studio (Effettivo)

28 febbraio 2024

Date di iscrizione allo studio

Primo inviato

8 febbraio 2021

Primo inviato che soddisfa i criteri di controllo qualità

10 febbraio 2021

Primo Inserito (Effettivo)

11 febbraio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CRO-2020-CAR-ARG-ED

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

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 .

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