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

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

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste; Drug: 1.5% Arginine Dentifrice; Drug: 8.0% Arginine Dentifrice

• Study Type: Interventional
• Enrollment (Actual): 6000
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400016
    • School of Stomatology Chongqing Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • School of Stomatology, Xian Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China School of Stomatology, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 0.32% Sodium Fluoride Dentifrice Toothpaste; Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study	Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste; Toothpaste
EXPERIMENTAL: 1.5% Arginine Dentifrice Toothpaste; Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study	Drug: 1.5% Arginine Dentifrice; Toothpaste
EXPERIMENTAL: 8.0% Arginine Dentifrice Toothpaste; Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study	Drug: 8.0% Arginine Dentifrice; Toothpaste

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Study Director: Yun Po E Zhang, PhD, DDS(Hons), Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): March 12, 2022
• Study Completion (ACTUAL): March 12, 2022

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (ACTUAL): September 30, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: prevention; fluoride; caries; arginine; ICDAS; DMFS
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: CRO-2018-12-CAR-ARG-YPZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No