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

Colgate-Palmolive

Status and phase: Withdrawn; Phase 2

Conditions: Dental Caries

Treatments: Drug: 1.1% Fluoride toothpaste; Drug: Fluoride Free toothpaste; Drug: 0.243% Fluoride toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT02708160

ERO-2015-CAI-03-RPS

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Fluoride Free toothpaste

Placebo Comparator group

Description:

Fluoride free (0%), silica based toothpaste

Treatment:

Drug: 0.243% Fluoride toothpaste

Drug: Fluoride Free toothpaste

Drug: 1.1% Fluoride toothpaste

1.1% Fluoride toothpaste

Experimental group

Description:

Prevident 5000 Plus, silica based toothpaste

Treatment:

Drug: 0.243% Fluoride toothpaste

Drug: Fluoride Free toothpaste

Drug: 1.1% Fluoride toothpaste

0.243% Fluoride Toothpaste

Active Comparator group

Description:

silica based fluoride toothpaste

Treatment:

Drug: 0.243% Fluoride toothpaste

Drug: Fluoride Free toothpaste

Drug: 1.1% Fluoride toothpaste