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Completed

NCT Number: NCT04750902

A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Puerto Rico School of Dental Medicine, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects meeting all criteria below will be included in the study:
  • Subject assent and parental/guardian informed consent for voluntary participation.
  • Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
  • Children ages 10-14 years at baseline.
  • Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa.
  • Good general health as evidenced by a review of the medical history.
  • Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT >1), D= Decayed is defined as ICDAS scores of 3 or greater

Exclusion criteria

  • Subjects presenting any of the criteria below will be excluded from the study:
  • Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.
  • Use of medication that could increase the risk of developing dental caries, i.e.

medications that reduce saliva flow and those with high sugar content.

  • Long-term antibiotic therapy.
  • Children with a confirmed diagnosis of cognitive and/or motor impairment.
  • Severe malocclusion.
  • Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
  • Evidence of moderate to severe periodontal disease.
  • Participation in any other clinical study within the 30 days preceding the start of the clinical study.
  • Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
  • Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Treatment and study plan

0.24% Sodium Fluoride Dentifrice

Drug

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

1.5% Arginine Dentifrice

Drug

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

4.0% Arginine Dentifrice

Drug

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

8.0% Arginine Dentifrice

Drug

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Month 6 and Month 12 Visits

    Time frame: 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.

  3. Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 6 Visits

    Time frame: 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.

  4. Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Baseline and the Month 12 Visits

    Time frame: 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.

  5. Incremental Subject-wise Decayed Missing or Filled Teeth (DMFT) Score Between the Month 6 and the Month 12 Visits

    Time frame: 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.

  6. Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 6 Visits

    Time frame: 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.

  7. Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Severity Score Progressions Between the Baseline and the Month 12 Visits

    Time frame: 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.

  8. 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

    Time frame: 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.

  9. 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

    Time frame: 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.

  10. 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

    Time frame: 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.

  11. 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

    Time frame: 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.

  12. Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Baseline and the Month 6 Visits

    Time frame: 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.

  13. Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Progressions Between the Baseline and the Month 12 Visits

    Time frame: 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.

  14. 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

    Time frame: 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.

  15. Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Baseline and the Month 6 Visits

    Time frame: 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.

  16. Subject-wise Tallies of Clinically Significant International Caries Detection and Assessment System (ICDAS) Caries Activity Regressions Between the Baseline and the Month 12 Visits

    Time frame: 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.

  17. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-blind, Active-controlled Multi-center Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices With 1.5%, 4.0% and 8.0% Arginine Each in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2021
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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