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A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

Primary Purpose

Dental Caries

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
0.24% Sodium Fluoride Dentifrice
1.5% Arginine Dentifrice
4.0% 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, arginine, prevention, caries, ICDAS, DMFS

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects meeting all criteria below will be included in the study:

    1. Subject assent and parental/guardian informed consent for voluntary participation.
    2. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
    3. Children ages 10-14 years at baseline.
    4. Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa.
    5. Good general health as evidenced by a review of the medical history.
    6. Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT >1), D= Decayed is defined as ICDAS scores of 3 or greater

Exclusion Criteria:

  • Subjects presenting any of the criteria below will be excluded from the study:

    1. Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.

    2. Use of medication that could increase the risk of developing dental caries, i.e.

      medications that reduce saliva flow and those with high sugar content.

    3. Long-term antibiotic therapy.
    4. Children with a confirmed diagnosis of cognitive and/or motor impairment.
    5. Severe malocclusion.
    6. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
    7. Evidence of moderate to severe periodontal disease.
    8. Participation in any other clinical study within the 30 days preceding the start of the clinical study.
    9. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
    10. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Sites / Locations

  • Loma Linda University School of Dentistry
  • University of Florida College of Dentistry
  • Indiana University School of DentistryRecruiting
  • Tufts University School of Dental MedicineRecruiting
  • The Forsyth InstituteRecruiting
  • University at Buffalo School of Dental Medicine
  • University of Pennsylvania School of Dental Medicine
  • UT Health San Antonio School of Dentistry
  • University of Puerto Rico School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

0.24% Sodium Fluoride Dentifrice

1.5% Arginine Dentifrice

4.0% Arginine Dentifrice

8.0% Arginine Dentifrice

Arm Description

Toothpaste

Toothpaste

Toothpaste

Toothpaste

Outcomes

Primary Outcome Measures

The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one 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

Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months 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
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one 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
Clinically significant change in International Caries Detection and Assessment System (ICDAS) severity scores between the baseline and the six-month and one-year examinations and between the six-month and one-year examinations.
the minimum score is 0, maximum score is 6 and a higher score represents a worse outcome
Clinically significant changes indicating caries progression are changes in ICDAS severity values from 0 to 2 or higher, from 1 or 2 to 3 or higher, or from 3 or 4 to 5 or 6.
Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.

Full Information

First Posted
February 8, 2021
Last Updated
February 7, 2023
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT04750902
Brief Title
A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children
Official Title
A Phase 2 Randomized, Double-blind, Active-controlled Multi-center Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices With 1.5%, 4.0% and 8.0% Arginine Each in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

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
Yes
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 assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.24% Sodium Fluoride Dentifrice
Arm Type
Active Comparator
Arm Description
Toothpaste
Arm Title
1.5% Arginine Dentifrice
Arm Type
Experimental
Arm Description
Toothpaste
Arm Title
4.0% Arginine Dentifrice
Arm Type
Experimental
Arm Description
Toothpaste
Arm Title
8.0% Arginine Dentifrice
Arm Type
Experimental
Arm Description
Toothpaste
Intervention Type
Drug
Intervention Name(s)
0.24% Sodium Fluoride Dentifrice
Intervention 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)
1.5% Arginine Dentifrice
Intervention 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)
4.0% Arginine Dentifrice
Intervention 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)
8.0% Arginine Dentifrice
Intervention Description
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one 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
one year
Secondary Outcome Measure Information:
Title
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months 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
after 6 months
Title
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one 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
between 6-months and one year
Title
Clinically significant change in International Caries Detection and Assessment System (ICDAS) severity scores between the baseline and the six-month and one-year examinations and between the six-month and one-year examinations.
Description
the minimum score is 0, maximum score is 6 and a higher score represents a worse outcome
Time Frame
between 6-months and one year
Title
Clinically significant changes indicating caries progression are changes in ICDAS severity values from 0 to 2 or higher, from 1 or 2 to 3 or higher, or from 3 or 4 to 5 or 6.
Time Frame
6 months
Title
Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.
Time Frame
12 months

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: Subjects meeting all criteria below will be included in the study: Subject assent and parental/guardian informed consent for voluntary participation. 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 permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa. Good general health as evidenced by a review of the medical history. Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT >1), D= Decayed is defined as ICDAS scores of 3 or greater Exclusion Criteria: Subjects presenting 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. medications that reduce saliva flow and those with high sugar content. Long-term antibiotic therapy. Children with a confirmed diagnosis of cognitive and/or motor impairment. Severe malocclusion. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth. Evidence of moderate to severe periodontal disease. Participation in any other clinical study within the 30 days preceding the start of the clinical study. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenick T Zero, DDS, MS
Phone
317-274-5429
Email
dzero@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Tran
Phone
317-274-3306
Email
jelbruce@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E Ryan, DDS PhD
Organizational Affiliation
Colgate-Palmolive Company
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University School of Dentistry
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiming Li, DDS MSD PhD
Phone
909-558-8069
Email
yli@llu.edu
First Name & Middle Initial & Last Name & Degree
Yiming Li, DDS MSD PhD
Facility Name
University of Florida College of Dentistry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelle Nascimento, DDS MS PhD
Phone
352-273-5858
Email
MNASCIMENTO@dental.ufl.edu
First Name & Middle Initial & Last Name & Degree
Marcelle Nascimento, DDS MS PhD
Facility Name
Indiana University School of Dentistry
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2876
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenick Zero, DDS MS
Phone
317-274-5429
Email
dzero@iu.edu
First Name & Middle Initial & Last Name & Degree
Domenick Zero, DDS MS
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Zandona, DDS MSD PhD
Phone
617-636-0325
Email
Andrea.Zandona@tufts.edu
First Name & Middle Initial & Last Name & Degree
Andrea Zandona, DDS MSD PhD
Facility Name
The Forsyth Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hatice Hasturk, DDS PhD
Phone
617-892-8499
Email
hhasturk@forsyth.org
First Name & Middle Initial & Last Name & Degree
Hatice Hasturk, DDS PhD
Facility Name
University at Buffalo School of Dental Medicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violet I Haraszthy, DDS MS PhD
Phone
716-829-3940
Email
vh1@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Violet I Haraszthy, DDS MS PhD
Facility Name
University of Pennsylvania School of Dental Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-6003
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hershkowitz, DDS AAS
Phone
212-992-7057
Email
dhh1@upenn.edu
First Name & Middle Initial & Last Name & Degree
David Hershkowitz, DDS AAS
Facility Name
UT Health San Antonio School of Dentistry
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS MSc PhD
Phone
210-567-3185
Email
amaechi@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Bennett T Amaechi, BDS MSc PhD
Facility Name
University of Puerto Rico School of Dental Medicine
City
San Juan
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Augusto R Elias Boneta, DMD MSD
Phone
787-765-0291
Email
dentalresearchassociates@gmail.com
First Name & Middle Initial & Last Name & Degree
Augusto R Elias Boneta, DMD MSD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

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