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

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
0.32% Sodium Fluoride Dentifrice Toothpaste
1.5% Arginine Dentifrice
8.0% Arginine Dentifrice
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring fluoride, prevention, caries, ICDAS, DMFS, arginine

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Stomatology, Xian Jiaotong University
  • West China School of Stomatology, Sichuan University
  • School of Stomatology Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

0.32% Sodium Fluoride Dentifrice Toothpaste

1.5% Arginine Dentifrice Toothpaste

8.0% Arginine Dentifrice Toothpaste

Arm Description

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2022
Last Updated
September 29, 2022
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT05560945
Brief Title
2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
March 12, 2022 (Actual)
Study Completion Date
March 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
fluoride, prevention, caries, ICDAS, DMFS, arginine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.32% Sodium Fluoride Dentifrice Toothpaste
Arm Type
Active Comparator
Arm Description
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Arm Title
1.5% Arginine Dentifrice Toothpaste
Arm Type
Experimental
Arm Description
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Arm Title
8.0% Arginine Dentifrice Toothpaste
Arm Type
Experimental
Arm Description
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Intervention Type
Drug
Intervention Name(s)
0.32% Sodium Fluoride Dentifrice Toothpaste
Intervention Description
Toothpaste
Intervention Type
Drug
Intervention Name(s)
1.5% Arginine Dentifrice
Intervention Description
Toothpaste
Intervention Type
Drug
Intervention Name(s)
8.0% Arginine Dentifrice
Intervention Description
Toothpaste
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces score after 2 year product use.
Description
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Time Frame
2 year
Title
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Teeth scores after two year of product use.
Description
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Po E Zhang, PhD, DDS(Hons)
Organizational Affiliation
Colgate Palmolive
Official's Role
Study Director
Facility Information:
Facility Name
School of Stomatology, Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
West China School of Stomatology, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
School of Stomatology Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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