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

Phase 2

Withdrawn

• Conditions: Dental Caries
• Interventions: Drug: Fluoride Free toothpaste; Drug: 1.1% Fluoride toothpaste; Drug: 0.243% Fluoride toothpaste

• Registration Number: NCT02708160
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluoride Free toothpaste	1.1% Fluoride toothpaste	Fluoride free (0%), silica based toothpaste
Fluoride Free toothpaste	Fluoride Free toothpaste	Fluoride free (0%), silica based toothpaste
Fluoride Free toothpaste	0.243% Fluoride toothpaste	Fluoride free (0%), silica based toothpaste
1.1% Fluoride toothpaste	Fluoride Free toothpaste	Prevident 5000 Plus, silica based toothpaste
1.1% Fluoride toothpaste	0.243% Fluoride toothpaste	Prevident 5000 Plus, silica based toothpaste
1.1% Fluoride toothpaste	1.1% Fluoride toothpaste	Prevident 5000 Plus, silica based toothpaste
0.243% Fluoride Toothpaste	0.243% Fluoride toothpaste	silica based fluoride toothpaste
0.243% Fluoride Toothpaste	Fluoride Free toothpaste	silica based fluoride toothpaste
0.243% Fluoride Toothpaste	1.1% Fluoride toothpaste	silica based fluoride toothpaste

Primary Outcome Measures

Name	Time	Method
Mineral Change (delta Z)	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).