NCT05560945

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2019

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

2.9 years

First QC Date

September 27, 2022

Last Update Submit

September 29, 2022

Conditions

Dental Caries

Keywords

fluoridepreventioncariesICDASDMFSarginine

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

0.32% Sodium Fluoride Dentifrice Toothpaste

ACTIVE COMPARATOR

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

1.5% Arginine Dentifrice Toothpaste

EXPERIMENTAL

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

8.0% Arginine Dentifrice Toothpaste

EXPERIMENTAL

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

Interventions

0.32% Sodium Fluoride Dentifrice ToothpasteDRUG

Toothpaste

0.32% Sodium Fluoride Dentifrice Toothpaste
1.5% Arginine DentifriceDRUG

Toothpaste

1.5% Arginine Dentifrice Toothpaste
8.0% Arginine DentifriceDRUG

Toothpaste

8.0% Arginine Dentifrice Toothpaste

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

School of Stomatology, Xian Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

West China School of Stomatology, Sichuan University

Chengdu, Sichuan, 610041, China

Location

School of Stomatology Chongqing Medical University

Chongqing, 400016, China

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Yun Po E Zhang, PhD, DDS(Hons)

    Colgate Palmolive

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

April 15, 2019

Primary Completion

March 12, 2022

Study Completion

March 12, 2022

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)