Un ensayo clínico para evaluar la seguridad y la eficacia anticaries de los dentífricos sin fluoruro COL 101 (arginina) en comparación con el control de dentífricos con fluoruro de sodio al 0,24 % (1100 Ppm F) en niños de 10 a 14 años
20 de julio de 2026 actualizado por: Colgate Palmolive
Un ensayo clínico multicéntrico, aleatorizado, doble ciego, con control activo, de fase 2 para evaluar la seguridad y la eficacia anticaries de los dentífricos sin flúor COL 101 (arginina) con 1,5 %, 4,0 % y 8,0 % de arginina cada uno en comparación Con fluoruro de sodio al 0,24 % (1100 Ppm F) Control de dentífrico en niños de 10 a 14 años
El objetivo de este estudio es evaluar la seguridad y evaluar la eficacia anticaries de los dentífricos sin fluoruro COL101 (arginina) en comparación con un dentífrico con fluoruro de sodio al 0,24 % en niños de 10 a 14 años durante un período de un año.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
2025
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Loma Linda, California, Estados Unidos, 92350
- Loma Linda University School of Dentistry
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida College of Dentistry
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-2876
- Indiana University School of Dentistry
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts University School of Dental Medicine
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Boston, Massachusetts, Estados Unidos, 02142
- The Forsyth Institute
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New York
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Buffalo, New York, Estados Unidos, 14214
- University at Buffalo School of Dental Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-6003
- University of Pennsylvania School of Dental Medicine
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Texas
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San Antonio, Texas, Estados Unidos, 78229-3900
- UT Health San Antonio School of Dentistry
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San Juan, Puerto Rico
- University of Puerto Rico School of Dental Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
10 años a 14 años (Niño)
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
Los sujetos que cumplan con todos los criterios a continuación serán incluidos en el estudio:
- Asentimiento del sujeto y consentimiento informado de los padres/tutores para la participación voluntaria.
- Voluntad y capacidad para usar los productos asignados de acuerdo con las instrucciones, disponibilidad para todas las citas y probabilidad de completar el ensayo clínico.
- Niños de 10 a 14 años al inicio del estudio.
- Presencia de segundos molares permanentes o evidencia de al menos un segundo molar permanente en erupción como lo indica la ruptura de la cúspide a través de la mucosa.
- Buen estado general de salud evidenciado por la revisión de la historia clínica.
- Sujetos que, al ingresar al estudio, presenten dos o más lesiones de caries activas (puntuaciones ICDAS de 2 o más) en dientes permanentes y experiencia previa de caries (DMFT >1), D= Caries se define como puntuaciones ICDAS de 3 o más
Criterio de exclusión:
Los sujetos que presenten alguno de los siguientes criterios serán excluidos del estudio:
- Presencia de aparato protésico fijo o removible o tratamiento de ortodoncia que involucre más de cuatro dientes permanentes.
Uso de medicamentos que podrían aumentar el riesgo de desarrollar caries dental, p.
medicamentos que reducen el flujo de saliva y aquellos con alto contenido de azúcar.
- Terapia antibiótica a largo plazo.
- Niños con diagnóstico confirmado de deterioro cognitivo y/o motor.
- Maloclusión severa.
- Sujetos que, al ingresar al estudio, presenten caries severa (ICDAS 5 o 6) en cinco o más dientes permanentes.
- Evidencia de enfermedad periodontal de moderada a grave.
- Participación en cualquier otro estudio clínico dentro de los 30 días anteriores al inicio del estudio clínico.
- Antecedentes conocidos de alergias u otras reacciones adversas a la arginina, a los productos para el cuidado bucal o a sus ingredientes.
- Antecedentes autoinformados de estar actualmente embarazada, tener la intención de quedar embarazada durante el período de prueba o amamantar.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Dentífrico con fluoruro de sodio al 0,24 %
Pasta dental
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Cepillado de toda la boca con pasta dental, 2 veces al día durante 2 minutos cada vez durante la duración del estudio
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Experimental: 1,5% Arginina Dentífrico
Pasta dental
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Cepillado de toda la boca con pasta dental, 2 veces al día durante 2 minutos cada vez durante la duración del estudio
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Experimental: 4,0% Arginina Dentífrico
Pasta dental
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Cepillado de toda la boca con pasta dental, 2 veces al día durante 2 minutos cada vez durante la duración del estudio
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Experimental: 8,0% Arginina Dentífrico
Pasta dental
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Cepillado de toda la boca con pasta dental, 2 veces al día durante 2 minutos cada vez durante la duración del estudio
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
Periodo de tiempo: 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.
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Between the Baseline and the Month 12 visits
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
Periodo de tiempo: 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
|
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Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Month 6 and Month 12 Visits
Periodo de tiempo: 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
|
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Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 6 Visits
Periodo de tiempo: 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.
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Between the Baseline and the Month 6 visits
|
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Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 12 Visits
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Between the Month 6 and the Month 12 visits
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Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 6 Visits
Periodo de tiempo: 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.
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Between the Baseline and the Month 6 visits
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Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 12 Visits
Periodo de tiempo: 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
|
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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
Periodo de tiempo: 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.
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Between the Month 6 and the Month 12 visits
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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
Periodo de tiempo: 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
|
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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
Periodo de tiempo: 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
|
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Maria E Ryan, DDS PhD, Colgate-Palmolive Company
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de enero de 2021
Finalización primaria (Actual)
28 de febrero de 2024
Finalización del estudio (Actual)
28 de febrero de 2024
Fechas de registro del estudio
Enviado por primera vez
8 de febrero de 2021
Primero enviado que cumplió con los criterios de control de calidad
10 de febrero de 2021
Publicado por primera vez (Actual)
11 de febrero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRO-2020-CAR-ARG-ED
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .