10 歳から 14 歳の子供を対象に、0.24% フッ化ナトリウム (1100 Ppm F) 歯磨剤コントロールと比較して、COL 101 (アルギニン) 非フッ化物歯磨剤の安全性と虫歯予防効果を評価する臨床試験
2026年7月20日 更新者：Colgate Palmolive
COL 101 (アルギニン) 非フッ化物歯磨剤の安全性と虫歯予防効果を評価するための第 2 相無作為化二重盲検実薬対照多施設臨床試験 (それぞれ 1.5%、4.0%、および 8.0% アルギニンを比較) 0.24% フッ化ナトリウム (1100 Ppm F) による 10 歳から 14 歳の子供の歯磨剤コントロール
この研究の目的は、COL101 (アルギニン) 非フッ化物歯磨剤の安全性を評価し、10-14 歳の子供の 0.24% フッ化ナトリウム歯磨剤と比較して、1 年間の虫歯予防効果を評価することです。
調査の概要
状態
状態
完了
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
介入
入学 (実際)
入学
2025
段階
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Loma Linda、California、アメリカ、92350
- Loma Linda University School of Dentistry
-
-
Florida
-
Gainesville、Florida、アメリカ、32610
- University of Florida College of Dentistry
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46202-2876
- Indiana University School of Dentistry
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02111
- Tufts University School of Dental Medicine
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Boston、Massachusetts、アメリカ、02142
- The Forsyth Institute
-
-
New York
-
Buffalo、New York、アメリカ、14214
- University at Buffalo School of Dental Medicine
-
-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104-6003
- University of Pennsylvania School of Dental Medicine
-
-
Texas
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San Antonio、Texas、アメリカ、78229-3900
- UT Health San Antonio School of Dentistry
-
-
-
-
-
San Juan、プエルトリコ
- University of Puerto Rico School of Dental Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
10年～14年 (子)
健康ボランティアの受け入れ
はい
説明
包含基準:
以下のすべての基準を満たす被験者が研究に含まれます。
- -被験者の同意および親/保護者の自発的な参加に対するインフォームドコンセント。
- 指示に従って割り当てられた製品を使用する意欲と能力、すべての予約の可用性、および臨床試験を完了する可能性。
- ベースラインで10〜14歳の子供。
- 永久第二大臼歯の存在、または粘膜の咬頭破裂によって示されるように、少なくとも1つの永久第二大臼歯の萌出の証拠。
- 病歴のレビューによって証明されるように、良好な一般的な健康状態。
- -研究登録時に、永久歯に2つ以上のアクティブな虫歯病変（2以上のICDASスコア）があり、以前の虫歯の経験がある被験者（DMFT> 1）、D = Decayedは、3以上のICDASスコアとして定義されます
除外基準:
以下の基準のいずれかを示す被験者は、研究から除外されます。
- 4本以上の永久歯を含む固定または取り外し可能な補綴物または矯正治療の存在。
虫歯を発症するリスクを高める可能性のある薬の使用。
唾液の流れを減らす薬と糖分の多い薬。
- 長期の抗生物質療法。
- -認知および/または運動障害の診断が確認された子供。
- 重度の不正咬合。
- -研究登録時に、5本以上の永久歯に重度のう蝕（ICDAS 5または6）がある被験者。
- 中度から重度の歯周病の証拠。
- -臨床試験開始前の30日以内の他の臨床試験への参加。
- アルギニン、口腔ケア製品、またはそれらの成分に対するアレルギーまたはその他の有害反応の既知の病歴。
- -現在妊娠中、試用期間中に妊娠する予定、または授乳中の自己申告歴。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
4
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：0.24% フッ化ナトリウム歯磨剤
歯磨き粉
|
研究期間中、歯磨き粉を使った口全体のブラッシング、1 日 2 回、毎回 2 分間
|
|
実験的：1.5% アルギニン歯磨剤
歯磨き粉
|
研究期間中、歯磨き粉を使った口全体のブラッシング、1 日 2 回、毎回 2 分間
|
|
実験的：4.0% アルギニン歯磨剤
歯磨き粉
|
研究期間中、歯磨き粉を使った口全体のブラッシング、1 日 2 回、毎回 2 分間
|
|
実験的：8.0% アルギニン歯磨剤
歯磨き粉
|
研究期間中、歯磨き粉を使った口全体のブラッシング、1 日 2 回、毎回 2 分間
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
捜査官
- スタディディレクター：Maria E Ryan, DDS PhD、Colgate-Palmolive Company
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2021年1月21日
一次修了 (実際)
一次修了
2024年2月28日
研究の完了 (実際)
研究の完了
2024年2月28日
試験登録日
最初に提出
最初に提出
2021年2月8日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2021年2月10日
最初の投稿 (実際)
最初の投稿
2021年2月11日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月21日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月20日
最終確認日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CRO-2020-CAR-ARG-ED
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。