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

Phase 3

Completed

• Conditions: Dental Caries
• Interventions: Drug: 8.0% Arginine Dentifrice; Drug: 1.5% Arginine Dentifrice; Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste

• Registration Number: NCT05560945
• Lead Sponsor: Colgate Palmolive

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2022-03-12
• Study Completion: 2022-03-12
• Status Verified: 2022-09
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Last Update Submitted: 2022-09-29
• Study First Posted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8.0% Arginine Dentifrice Toothpaste	8.0% Arginine Dentifrice	Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
1.5% Arginine Dentifrice Toothpaste	1.5% Arginine Dentifrice	Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
0.32% Sodium Fluoride Dentifrice Toothpaste	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

Primary Outcome Measures

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

Trial Locations

Locations (3)

West China School of Stomatology, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

School of Stomatology Chongqing Medical University; 🇨🇳 Chongqing, China

School of Stomatology, Xian Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China