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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

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ClinicalTrials.gov Identifier: NCT04750902
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: 0.24% Sodium Fluoride Dentifrice Drug: 1.5% Arginine Dentifrice Drug: 4.0% Arginine Dentifrice Drug: 8.0% Arginine Dentifrice Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 0.24% Sodium Fluoride Dentifrice
Toothpaste
Drug: 0.24% Sodium Fluoride Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Experimental: 1.5% Arginine Dentifrice
Toothpaste
Drug: 1.5% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Experimental: 4.0% Arginine Dentifrice
Toothpaste
Drug: 4.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study

Experimental: 8.0% Arginine Dentifrice
Toothpaste
Drug: 8.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study




Primary Outcome Measures :
  1. The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use [ Time Frame: one year ]
    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 :
  1. Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use; [ Time Frame: after 6 months ]
    the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome

  2. Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use. [ Time Frame: between 6-months and one year ]
    the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome

  3. 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. [ Time Frame: between 6-months and one year ]
    the minimum score is 0, maximum score is 6 and a higher score represents a worse outcome

  4. 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 ]
  5. Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1. [ Time Frame: 12 months ]


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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750902


Contacts
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Contact: Domenick T Zero, DDS, MS 317-274-5429 dzero@iu.edu
Contact: Jennifer Tran 317-274-3306 jelbruce@iu.edu

Locations
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United States, California
Loma Linda University School of Dentistry Not yet recruiting
Loma Linda, California, United States, 92350
Contact: Yiming Li, DDS MSD PhD    909-558-8069    yli@llu.edu   
Principal Investigator: Yiming Li, DDS MSD PhD         
United States, Florida
University of Florida College of Dentistry Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Marcelle Nascimento, DDS MS PhD    352-273-5858    MNASCIMENTO@dental.ufl.edu   
Principal Investigator: Marcelle Nascimento, DDS MS PhD         
United States, Indiana
Indiana University School of Dentistry Recruiting
Indianapolis, Indiana, United States, 46202-2876
Contact: Domenick Zero, DDS MS    317-274-5429    dzero@iu.edu   
Principal Investigator: Domenick Zero, DDS MS         
United States, Massachusetts
Tufts University School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02111
Contact: Andrea Zandona, DDS MSD PhD    617-636-0325    Andrea.Zandona@tufts.edu   
Principal Investigator: Andrea Zandona, DDS MSD PhD         
The Forsyth Institute Recruiting
Boston, Massachusetts, United States, 02142
Contact: Hatice Hasturk, DDS PhD    617-892-8499    hhasturk@forsyth.org   
Principal Investigator: Hatice Hasturk, DDS PhD         
United States, New York
University at Buffalo School of Dental Medicine Not yet recruiting
Buffalo, New York, United States, 14214
Contact: Violet I Haraszthy, DDS MS PhD    716-829-3940    vh1@buffalo.edu   
Principal Investigator: Violet I Haraszthy, DDS MS PhD         
United States, Pennsylvania
University of Pennsylvania School of Dental Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104-6003
Contact: David Hershkowitz, DDS AAS    212-992-7057    dhh1@upenn.edu   
Principal Investigator: David Hershkowitz, DDS AAS         
United States, Texas
UT Health San Antonio School of Dentistry Not yet recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Bennett T Amaechi, BDS MSc PhD    210-567-3185    amaechi@uthscsa.edu   
Principal Investigator: Bennett T Amaechi, BDS MSc PhD         
Puerto Rico
University of Puerto Rico School of Dental Medicine Not yet recruiting
San Juan, Puerto Rico
Contact: Augusto R Elias Boneta, DMD MSD    787-765-0291    dentalresearchassociates@gmail.com   
Principal Investigator: Augusto R Elias Boneta, DMD MSD         
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Study Director: Maria E Ryan, DDS PhD Colgate-Palmolive Company
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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT04750902    
Other Study ID Numbers: CRO-2020-CAR-ARG-ED
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Colgate Palmolive:
fluoride
arginine
prevention
caries
ICDAS
DMFS
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Listerine
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents