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

Sponsor

Colgate Palmolive (Industry)

Overall Status

Completed

CT.gov ID

NCT05560945

Collaborator

(none)

6,000

Enrollment

Locations

Arms

34.9

Actual Duration (Months)

2000

Patients Per Site

57.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste Drug: 1.5% Arginine Dentifrice Drug: 8.0% Arginine Dentifrice	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

6000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Apr 15, 2019

Actual Primary Completion Date :

Mar 12, 2022

Actual Study Completion Date :

Mar 12, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Stomatology, Xian Jiaotong University	Xi'an	Shaanxi	China	710004
2	West China School of Stomatology, Sichuan University	Chengdu	Sichuan	China	610041
3	School of Stomatology Chongqing Medical University	Chongqing		China	400016