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To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study

Primary Purpose

Dental Caries

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Control toothpaste containing no anti-cavity ingredients
Experimental toothpaste containing fluoride and amino acid (arginine)
Fluoride toothpaste containing fluoride as the anti-cavity ingredient
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male and/or female subjects 18 to 50 years inclusive
  2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
  3. Willing to wear retainer 24 hours per day
  4. No active, unrestored cavities
  5. Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
  6. Available throughout entire study
  7. Willing to use only assigned products for oral hygiene throughout the duration of the study
  8. Must give written informed consent
  9. Must be in good general health
  10. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

  1. Advanced periodontal disease
  2. Medical condition which requires premedication prior to dental visits/procedures
  3. Not enough teeth to secure the oral retainer
  4. Diseases of the soft or hard oral tissues
  5. Wear an Orthodontic appliances
  6. Impaired salivary function
  7. Current use drugs that can affect salivary flow
  8. Use antibiotics one (1) month prior to or during this study
  9. Pregnant or breastfeeding
  10. Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
  11. Use tobacco products
  12. Allergic to common toothpaste ingredients
  13. Allergic to amino acids
  14. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Active Comparator

    Arm Label

    Fluoride free, silica based toothpaste

    fluoride + amino acid in a silica toothpaste

    1450 ppm fluoride in a silica base toothpaste

    Arm Description

    Control toothpaste containing no anti-cavity ingredients

    Experimental toothpaste containing fluoride and amino acid (arginine)

    Fluoride toothpaste containing fluoride as the anti-cavity ingredient

    Outcomes

    Primary Outcome Measures

    Mineral Change (delta Z)
    Tooth samples of human enamel are placed in a retainer and worn by each study subject. Enamel block samples will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm) before being placed in the retainer. These baseline values will be compared with the post use delta mineral change (∆ Z).
    Mineral Change (delta Z)
    Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of wearing the study retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm). These post use values will be compared to the Baseline values to give a delta mineral change (∆ Z).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 4, 2015
    Last Updated
    September 24, 2022
    Sponsor
    Colgate Palmolive
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02388178
    Brief Title
    To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study
    Official Title
    Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was stopped due to business reasons.
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    July 2015 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluoride free, silica based toothpaste
    Arm Type
    Placebo Comparator
    Arm Description
    Control toothpaste containing no anti-cavity ingredients
    Arm Title
    fluoride + amino acid in a silica toothpaste
    Arm Type
    Experimental
    Arm Description
    Experimental toothpaste containing fluoride and amino acid (arginine)
    Arm Title
    1450 ppm fluoride in a silica base toothpaste
    Arm Type
    Active Comparator
    Arm Description
    Fluoride toothpaste containing fluoride as the anti-cavity ingredient
    Intervention Type
    Drug
    Intervention Name(s)
    Control toothpaste containing no anti-cavity ingredients
    Other Intervention Name(s)
    Fluoride free toothpaste control
    Intervention Description
    Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
    Intervention Type
    Drug
    Intervention Name(s)
    Experimental toothpaste containing fluoride and amino acid (arginine)
    Other Intervention Name(s)
    Experimental toothpaste
    Intervention Description
    Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
    Intervention Type
    Drug
    Intervention Name(s)
    Fluoride toothpaste containing fluoride as the anti-cavity ingredient
    Other Intervention Name(s)
    Fluoride only toothpaste control
    Intervention Description
    Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
    Primary Outcome Measure Information:
    Title
    Mineral Change (delta Z)
    Description
    Tooth samples of human enamel are placed in a retainer and worn by each study subject. Enamel block samples will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm) before being placed in the retainer. These baseline values will be compared with the post use delta mineral change (∆ Z).
    Time Frame
    Baseline
    Title
    Mineral Change (delta Z)
    Description
    Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of wearing the study retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm). These post use values will be compared to the Baseline values to give a delta mineral change (∆ Z).
    Time Frame
    2 weeks (from Baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male and/or female subjects 18 to 50 years inclusive Minimum of 20 natural uncrowned teeth (excluding third molars) must be present Willing to wear retainer 24 hours per day No active, unrestored cavities Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry Available throughout entire study Willing to use only assigned products for oral hygiene throughout the duration of the study Must give written informed consent Must be in good general health No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study Exclusion Criteria: Advanced periodontal disease Medical condition which requires premedication prior to dental visits/procedures Not enough teeth to secure the oral retainer Diseases of the soft or hard oral tissues Wear an Orthodontic appliances Impaired salivary function Current use drugs that can affect salivary flow Use antibiotics one (1) month prior to or during this study Pregnant or breastfeeding Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period Use tobacco products Allergic to common toothpaste ingredients Allergic to amino acids Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bennet Amaechi, PhD, DDS
    Organizational Affiliation
    University of Texas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study

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