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En klinisk utprøving for å vurdere sikkerheten og anti-karieseffektiviteten til tannpleiemidler uten fluor av COL 101 (arginin) sammenlignet med 0,24 % natriumfluorid (1100 ppm F) tannpleiekontroll hos 10 til 14 år gamle barn

20. juli 2026 oppdatert av: Colgate Palmolive

En fase 2 randomisert, dobbeltblind, aktivt kontrollert multisenter klinisk studie for å vurdere sikkerheten og anti-karieseffektiviteten til COL 101 (arginin) ikke-fluorid tannpleiemidler med 1,5 %, 4,0 % og 8,0 % arginin hver i sammenligning Med 0,24 % natriumfluorid (1100 ppm F) tannpleiekontroll hos 10 til 14 år gamle barn

Målet med denne studien er å vurdere sikkerheten og å evaluere anti-karies-effekten av COL101 (arginin) ikke-fluorid tannpleiemidler sammenlignet med et 0,24 % natriumfluorid tannpleiemiddel hos 10-14 år gamle barn over en ettårsperiode.

Studieoversikt

Status

Status

Indikerer gjeldende rekrutteringsstatus eller utvidet tilgangsstatus.
Fullført

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

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.

Studietype

Studietype

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

Registrering (Faktiske)

Registrering

Antall deltakere i en klinisk studie. Den "forventede" påmeldingen er måltallet for deltakere som forskerne trenger for studien.
2025

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.
  • Fase 2

Kontakter og plasseringer

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

Studiesteder

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

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

10 år til 14 år (Barn)

Tar imot friske frivillige

Ja

Beskrivelse

Inklusjonskriterier:

  • Emner som oppfyller alle kriteriene nedenfor vil bli inkludert i studien:

    1. Subjektets samtykke og informert samtykke fra foreldre/foresatte for frivillig deltakelse.
    2. Vilje og evne til å bruke de tildelte produktene i henhold til instruksjoner, tilgjengelighet for alle avtaler og sannsynlighet for å fullføre den kliniske utprøvingen.
    3. Barn i alderen 10-14 år ved baseline.
    4. Tilstedeværelse av permanente andre jeksler eller tegn på at minst én permanent andre jeksler bryter ut som indikert ved cuspal brudd gjennom slimhinnen.
    5. God generell helse som dokumentert ved en gjennomgang av sykehistorien.
    6. Forsøkspersoner som ved studiestart har presentert to eller flere aktive karieslesjoner (ICDAS-skår på 2 eller høyere) i permanente tenner og tidligere karieserfaring (DMFT >1), D= Decayed er definert som ICDAS-score på 3 eller høyere

Ekskluderingskriterier:

  • Emner som presenterer noen av kriteriene nedenfor vil bli ekskludert fra studien:

    1. Tilstedeværelse av fast eller avtakbart proteseapparat eller kjeveortopedisk behandling som involverer mer enn fire permanente tenner.

    2. Bruk av medisiner som kan øke risikoen for utvikling av tannkaries, d.v.s.

      medisiner som reduserer spyttstrømmen og de med høyt sukkerinnhold.

    3. Langvarig antibiotikabehandling.
    4. Barn med bekreftet diagnose kognitiv og/eller motorisk svikt.
    5. Alvorlig malocclusion.
    6. Forsøkspersoner som ved studiestart har alvorlig karies (ICDAS 5 eller 6) på fem eller flere permanente tenner.
    7. Bevis på moderat til alvorlig periodontal sykdom.
    8. Deltakelse i enhver annen klinisk studie innen 30 dager før starten av den kliniske studien.
    9. Kjent historie med allergier eller andre bivirkninger på arginin, eller munnpleieprodukter, eller deres ingredienser.
    10. Selvrapportert historie om å være gravid, har tenkt å bli gravid i løpet av prøveperioden eller amming.

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: Parallell tildeling
  • Masking: Firemannsrom

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.
Aktiv komparator: 0,24 % natriumfluorid tannpleiemiddel
Tannkrem
Legemiddel: 0,24 % natriumfluorid tannpleiemiddel
Børsting av hele munnen med tannkrem 2 ganger om dagen i 2 minutter hver gang i løpet av studien
Eksperimentell: 1,5% arginin tannpleiemiddel
Tannkrem
Legemiddel: 1,5% arginin tannpleiemiddel
Børsting av hele munnen med tannkrem 2 ganger om dagen i 2 minutter hver gang i løpet av studien
Eksperimentell: 4,0 % arginin tannpleiemiddel
Tannkrem
Legemiddel: 4,0 % arginin tannpleiemiddel
Børsting av hele munnen med tannkrem 2 ganger om dagen i 2 minutter hver gang i løpet av studien
Eksperimentell: 8,0 % arginin tannpleiemiddel
Tannkrem
Legemiddel: 8,0 % arginin tannpleiemiddel
Børsting av hele munnen med tannkrem 2 ganger om dagen i 2 minutter hver gang i løpet av studien

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
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
Tidsramme: 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

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
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

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.
Colgate Palmolive

Etterforskere

Etterforskere

En forsker involvert i en klinisk studie. Beslektede termer inkluderer stedets hovedetterforsker, stedsunderetterforsker, studieleder, studieleder og studiehovedetterforsker.
  • Studieleder: Maria E Ryan, DDS PhD, Colgate-Palmolive Company

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 (Faktiske)

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.
21. januar 2021

Primær fullføring (Faktiske)

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.
28. februar 2024

Studiet fullført (Faktiske)

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.
28. februar 2024

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).
8. februar 2021

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.
10. februar 2021

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.
11. februar 2021

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. juli 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.
20. juli 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. juli 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.
  • CRO-2020-CAR-ARG-ED

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

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. .

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