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2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste

Clinical Investigation Examining the Anticaries Efficacy of Three Dentifrices (1.5% Arginine in a Calcium Base, 8.0% Arginine in a Calcium Base, and 0.32% Sodium Fluoride in a Silica Base): a Two-year Caries Clinical Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05560945
Enrollment
6000
Registered
2022-09-30
Start date
2019-04-15
Completion date
2022-03-12
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

fluoride, prevention, caries, ICDAS, DMFS, arginine

Brief summary

The objective of this study is to evaluate the anticaries efficacy for three dentifrices (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride in a silica base) in a two-year caries clinical study

Interventions

DRUG0.32% Sodium Fluoride Dentifrice Toothpaste

Toothpaste

Sponsors

Colgate Palmolive
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* Informed Consent Form signed by parent or legal guardian to permit participation of their child in the study * 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 second molars or evidence of erupting permanent molars. * Subjects should be of good general health as evidenced by a review of the medical history. * Presence of two or more active caries lesions (ICDAS scores of 2 or greater) and with a previous caries experience (DMFS ≥ 2). Exclusion Characteristics * Subjects presenting with 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. medication that reduces saliva flow. * Long-term antibiotic therapy. * Children with cognitive and/or motor impairment. * Severe malocclusion. * Presence of severe caries (ICDAS 5 or 6) on five or more teeth. * Evidence of moderate to severe periodontal disease. * Participation in any other clinical study within the 30 days preceding the clinical study. * History of allergies or other adverse reactions to arginine, or oral care products, or their ingredients. * Pregnant or lactating.

Design outcomes

Primary

MeasureTime frameDescription
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use.2 yearthe minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Teeth scores after two year of product use.2 yearthe minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026