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

Colgate-Palmolive

Status and phase: Withdrawn; Phase 2

Conditions: Dental Caries

Treatments: Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient; Drug: Experimental toothpaste containing fluoride and amino acid (arginine); Drug: Control toothpaste containing no anti-cavity ingredients

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388178

ERO-2014-CAI-02-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 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)

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, silica based toothpaste

Placebo Comparator group

Description:

Control toothpaste containing no anti-cavity ingredients

Treatment:

Drug: Control toothpaste containing no anti-cavity ingredients

Drug: Experimental toothpaste containing fluoride and amino acid (arginine)

Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient

fluoride + amino acid in a silica toothpaste

Experimental group

Description:

Experimental toothpaste containing fluoride and amino acid (arginine)

Treatment:

Drug: Control toothpaste containing no anti-cavity ingredients

Drug: Experimental toothpaste containing fluoride and amino acid (arginine)

Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient

1450 ppm fluoride in a silica base toothpaste

Active Comparator group

Description:

Fluoride toothpaste containing fluoride as the anti-cavity ingredient

Treatment:

Drug: Control toothpaste containing no anti-cavity ingredients

Drug: Experimental toothpaste containing fluoride and amino acid (arginine)

Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient