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

NCT ID: NCT05560945

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2022-03-12

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

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

0.32% Sodium Fluoride Dentifrice Toothpaste

Intervention Type: DRUG

Toothpaste

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

Group Type: EXPERIMENTAL

1.5% Arginine Dentifrice

Intervention Type: DRUG

Toothpaste

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

Group Type: EXPERIMENTAL

8.0% Arginine Dentifrice

Intervention Type: DRUG

Toothpaste

Interventions

0.32% Sodium Fluoride Dentifrice Toothpaste

Toothpaste

Intervention Type: DRUG

1.5% Arginine Dentifrice

Toothpaste

Intervention Type: DRUG

8.0% Arginine Dentifrice

Toothpaste

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun Po E Zhang, PhD, DDS(Hons)

Role: STUDY_DIRECTOR

Colgate Palmolive

Locations

School of Stomatology, Xian Jiaotong University

Xi'an, Shaanxi, China

West China School of Stomatology, Sichuan University

Chengdu, Sichuan, China

School of Stomatology Chongqing Medical University

Chongqing, , China

Countries

China

Other Identifiers

CRO-2018-12-CAR-ARG-YPZ

Identifier Type: -

Identifier Source: org_study_id