一项评估 COL 101（精氨酸）非氟化物牙膏与 0.24% 氟化钠 (1100 Ppm F) 牙膏对照在 10 至 14 岁儿童中的安全性和防龋功效的临床试验
2026年7月20日 更新者：Colgate Palmolive
一项评估 COL 101（精氨酸）非氟化物牙膏的安全性和防龋功效的 2 期随机、双盲、主动控制多中心临床试验，其中精氨酸含量分别为 1.5%、4.0% 和 8.0%，并进行比较含 0.24% 氟化钠 (1100 Ppm F) 的牙膏控制 10 至 14 岁儿童
本研究的目的是评估 COL101（精氨酸）无氟牙膏与 0.24% 氟化钠牙膏在一年内对 10-14 岁儿童的安全性和防龋效果。
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
2025
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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San Juan、波多黎各
- University of Puerto Rico School of Dental Medicine
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California
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Loma Linda、California、美国、92350
- Loma Linda University School of Dentistry
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Florida
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Gainesville、Florida、美国、32610
- University of Florida College of Dentistry
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Indiana
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Indianapolis、Indiana、美国、46202-2876
- Indiana University School of Dentistry
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts University School of Dental Medicine
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Boston、Massachusetts、美国、02142
- The Forsyth Institute
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New York
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Buffalo、New York、美国、14214
- University at Buffalo School of Dental Medicine
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104-6003
- University of Pennsylvania School of Dental Medicine
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Texas
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San Antonio、Texas、美国、78229-3900
- UT Health San Antonio School of Dentistry
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 14年 (孩子)
接受健康志愿者
是的
描述
纳入标准：
符合以下所有标准的受试者将被纳入研究：
- 征得自愿参与的同意和父母/监护人的知情同意。
- 根据说明使用指定产品的意愿和能力、所有预约的可用性以及完成临床试验的可能性。
- 基线年龄为 10-14 岁的儿童。
- 存在第二恒磨牙或至少有一颗第二恒磨牙萌出的证据，如牙尖突破粘膜所示。
- 通过回顾病史证明总体健康状况良好。
- 受试者在进入研究时，在恒牙中出现两个或更多活动性龋齿病变（ICDAS 评分为 2 或更高）并且之前有龋齿经历（DMFT > 1），D= 龋齿定义为 ICDAS 评分为 3 或更高
排除标准：
呈现以下任何标准的受试者将被排除在研究之外：
- 存在固定或可移动的修复器具或涉及四个以上恒牙的正畸治疗。
使用可能增加患龋齿风险的药物，即
减少唾液流量的药物和含糖量高的药物。
- 长期抗生素治疗。
- 确诊患有认知和/或运动障碍的儿童。
- 严重咬合不正。
- 在研究开始时，有五颗或更多恒牙出现严重龋齿（ICDAS 5 或 6）的受试者。
- 中度至重度牙周病的证据。
- 在临床研究开始前 30 天内参加任何其他临床研究。
- 已知对精氨酸或口腔护理产品或其成分过敏或其他不良反应的历史。
- 自我报告的当前怀孕史，打算在试验期间或哺乳期间怀孕。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：0.24% 氟化钠牙膏
牙膏
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在研究期间，用牙膏全口刷牙，每天 2 次，每次 2 分钟
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实验性的：1.5% 精氨酸洁齿剂
牙膏
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在研究期间，用牙膏全口刷牙，每天 2 次，每次 2 分钟
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实验性的：4.0% 精氨酸洁齿剂
牙膏
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在研究期间，用牙膏全口刷牙，每天 2 次，每次 2 分钟
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实验性的：8.0% 精氨酸牙膏
牙膏
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在研究期间，用牙膏全口刷牙，每天 2 次，每次 2 分钟
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
大体时间：Between the Baseline and the Month 12 visits
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
大体时间：Between the Baseline and the Month 6 visits
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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 6 visits
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Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Month 6 and Month 12 Visits
大体时间：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.
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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
大体时间：Between the Baseline and the Month 6 visits
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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
|
|
Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 12 Visits
大体时间：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
大体时间：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
大体时间：Between the Baseline and the Month 6 visits
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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
大体时间：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.
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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
大体时间：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
大体时间：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.
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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) Caries Severity Score Regressions Between the Baseline and the Month 12 Visits
大体时间：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.
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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
大体时间：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.
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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 Activity Progressions Between the Baseline and the Month 6 Visits
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
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Between the Month 6 and the Month 12 visits
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Maria E Ryan, DDS PhD、Colgate-Palmolive Company
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月21日
初级完成 (实际的)
2024年2月28日
研究完成 (实际的)
2024年2月28日
研究注册日期
首次提交
2021年2月8日
首先提交符合 QC 标准的
2021年2月10日
首次发布 (实际的)
2021年2月11日
研究记录更新
最后更新发布 (实际的)
2026年7月21日
上次提交的符合 QC 标准的更新
2026年7月20日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.