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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560945
• Other study ID #: CRO-2018-12-CAR-ARG-YPZ
• Status: Completed
• Phase: Phase 3
• Start date: April 15, 2019
• Est. completion date: March 12, 2022

Study information

• Verified date: September 2022
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: March 12, 2022
• Est. primary completion date: March 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• 0.32% Sodium Fluoride Dentifrice Toothpaste
Toothpaste
• 1.5% Arginine Dentifrice
Toothpaste
• 8.0% Arginine Dentifrice
Toothpaste

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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