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Trial record 30 of 292 for:    Sodium Fluoride OR Duraphat

Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model

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ClinicalTrials.gov Identifier: NCT02708160
Recruitment Status : Withdrawn (Withdrawn due to business reasons)
First Posted : March 15, 2016
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Fluoride Free toothpaste Drug: 1.1% Fluoride toothpaste Drug: 0.243% Fluoride toothpaste Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model
Study Start Date : March 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Fluoride Free toothpaste
Fluoride free (0%), silica based toothpaste
Drug: Fluoride Free toothpaste
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 1 minute before rinsing with water.
Other Name: Control toothpaste containing no anti-cavity ingredients

Drug: 1.1% Fluoride toothpaste
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 1 minute before rinsing with water.
Other Name: Prevident 5000 Plus

Drug: 0.243% Fluoride toothpaste
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 1 minute before rinsing with water.
Other Name: silica based fluoride toothpaste

Experimental: 1.1% Fluoride toothpaste
Prevident 5000 Plus, silica based toothpaste
Drug: Fluoride Free toothpaste
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 1 minute before rinsing with water.
Other Name: Control toothpaste containing no anti-cavity ingredients

Drug: 1.1% Fluoride toothpaste
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 1 minute before rinsing with water.
Other Name: Prevident 5000 Plus

Drug: 0.243% Fluoride toothpaste
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 1 minute before rinsing with water.
Other Name: silica based fluoride toothpaste

Active Comparator: 0.243% Fluoride Toothpaste
silica based fluoride toothpaste
Drug: Fluoride Free toothpaste
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 1 minute before rinsing with water.
Other Name: Control toothpaste containing no anti-cavity ingredients

Drug: 1.1% Fluoride toothpaste
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 1 minute before rinsing with water.
Other Name: Prevident 5000 Plus

Drug: 0.243% Fluoride toothpaste
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 1 minute before rinsing with water.
Other Name: silica based fluoride toothpaste




Primary Outcome Measures :
  1. Mineral Change (delta Z) [ Time Frame: Baseline ]
    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 ( ΔZ).

  2. Mineral Change (delta Z) [ Time Frame: 2 weeks (from Baseline) ]
    Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of brushing while wearing the study oral 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 ( ΔZ).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 retainer(s)
  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. Positive urine test for pregnancy (a urine pregnancy test will be performed on female subjects of child-bearing potential)
  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 history to common toothpaste ingredients
  13. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history

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): NCT02708160


Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Bennet Amaechi, PhD, DDS University of Texas

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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02708160     History of Changes
Other Study ID Numbers: ERO-2015-CAI-03-RPS
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents