Status:
COMPLETED
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
Lead Sponsor:
Colgate Palmolive
Conditions:
Dental Caries
Eligibility:
All Genders
10-14 years
Phase:
PHASE2
Brief Summary
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04750902
Start Date
January 21 2021
End Date
February 29 2024
Last Update
May 16 2024
Active Locations (9)
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1
Loma Linda University School of Dentistry
Loma Linda, California, United States, 92350
2
University of Florida College of Dentistry
Gainesville, Florida, United States, 32610
3
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202-2876
4
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111