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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,025
- 试验地点
- 14
- 主要终点
- The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
0.24% Sodium Fluoride Dentifrice
Toothpaste
干预措施: 0.24% Sodium Fluoride Dentifrice (Drug)
1.5% Arginine Dentifrice
Toothpaste
干预措施: 1.5% Arginine Dentifrice (Drug)
8.0% Arginine Dentifrice
Toothpaste
干预措施: 8.0% Arginine Dentifrice (Drug)
4.0% Arginine Dentifrice
Toothpaste
干预措施: 4.0% Arginine Dentifrice (Drug)
结局指标
主要结局
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use
时间窗: one year
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits
时间窗: 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.
次要结局
- Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use;(after 6 months)
- Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use.(between 6-months and one year)
- Clinically significant change in International Caries Detection and Assessment System (ICDAS) severity scores between the baseline and the six-month and one-year examinations and between the six-month and one-year examinations.(between 6-months and one year)
- Clinically significant changes indicating caries progression are changes in ICDAS severity values from 0 to 2 or higher, from 1 or 2 to 3 or higher, or from 3 or 4 to 5 or 6.(6 months)
- Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.(12 months)
- Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 6 Visits(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(Between the Month 6 and the Month 12 visits)