- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02708160
Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model
February 19, 2019 updated by: Colgate Palmolive
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 retainer(s)
- Impaired salivary function
- Current use drugs that can affect salivary flow
- Use antibiotics one (1) month prior to or during this study
- Positive urine test for pregnancy (a urine pregnancy test will be performed on female subjects of child-bearing potential)
- 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 history to common toothpaste ingredients
- Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Fluoride Free toothpaste
Fluoride free (0%), silica based 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 Names:
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 Names:
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 Names:
|
Experimental: 1.1% Fluoride toothpaste
Prevident 5000 Plus, silica based 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 Names:
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 Names:
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 Names:
|
Active Comparator: 0.243% Fluoride Toothpaste
silica based 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 Names:
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline
|
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).
|
2 weeks (from Baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bennet Amaechi, PhD, DDS, University of Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
March 4, 2016
First Submitted That Met QC Criteria
March 9, 2016
First Posted (Estimate)
March 15, 2016
Study Record Updates
Last Update Posted (Actual)
February 21, 2019
Last Update Submitted That Met QC Criteria
February 19, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERO-2015-CAI-03-RPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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