Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: fluoride
arginine
prevention
caries
ICDAS
DMFS
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2021-02-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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-old children over a one year period.


Eligibility criteria: Inclusion Criteria:

* Subjects meeting all criteria below will be included in the study:

  1. Subject assent and parental/guardian informed consent for voluntary participation.
  2. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
  3. Children ages 10-14 years at baseline.
  4. Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa.
  5. Good general health as evidenced by a review of the medical history.
  6. 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:

  1. Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.
  2. 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.
  3. Long-term antibiotic therapy.
  4. Children with a confirmed diagnosis of cognitive and/or motor impairment.
  5. Severe malocclusion.
  6. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
  7. Evidence of moderate to severe periodontal disease.
  8. Participation in any other clinical study within the 30 days preceding the start of the clinical study.
  9. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
  10. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Primary outcomes:
measure: The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use
timeFrame: one year
Secondary outcomes:
measure: Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use;
timeFrame: after 6 months
measure: Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use.
timeFrame: between 6-months and one year
measure: 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.
timeFrame: between 6-months and one year
measure: 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.
timeFrame: 6 months
measure: Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.
timeFrame: 12 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Dentistry
state: California
city: Gainesville
country: United States
facility: University of Florida College of Dentistry
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
city: Boston
country: United States
facility: The Forsyth Institute
state: Massachusetts
city: Buffalo
country: United States
facility: University at Buffalo School of Dental Medicine
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Dental Medicine
state: Pennsylvania
city: San Antonio
country: United States
facility: UT Health San Antonio School of Dentistry
state: Texas
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico School of Dental Medicine
Study officials:
affiliation: Colgate-Palmolive Company
name: Maria E Ryan, DDS PhD
role: STUDY_DIRECTOR
References: