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

Phase 2

Withdrawn

• Conditions: Dental Caries
• Interventions: 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

• Registration Number: NCT02388178
• 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 First Submitted: 2015-02-04
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-13
• Study Start: 2015-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-24
• Last Update Posted: 2022-09-27

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• Status: WITHDRAWN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 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluoride free, silica based toothpaste	Control toothpaste containing no anti-cavity ingredients	Control toothpaste containing no anti-cavity ingredients
1450 ppm fluoride in a silica base toothpaste	Experimental toothpaste containing fluoride and amino acid (arginine)	Fluoride toothpaste containing fluoride as the anti-cavity ingredient
fluoride + amino acid in a silica toothpaste	Fluoride toothpaste containing fluoride as the anti-cavity ingredient	Experimental toothpaste containing fluoride and amino acid (arginine)
1450 ppm fluoride in a silica base toothpaste	Control toothpaste containing no anti-cavity ingredients	Fluoride toothpaste containing fluoride as the anti-cavity ingredient
1450 ppm fluoride in a silica base toothpaste	Fluoride toothpaste containing fluoride as the anti-cavity ingredient	Fluoride toothpaste containing fluoride as the anti-cavity ingredient
Fluoride free, silica based toothpaste	Fluoride toothpaste containing fluoride as the anti-cavity ingredient	Control toothpaste containing no anti-cavity ingredients
Fluoride free, silica based toothpaste	Experimental toothpaste containing fluoride and amino acid (arginine)	Control toothpaste containing no anti-cavity ingredients
fluoride + amino acid in a silica toothpaste	Control toothpaste containing no anti-cavity ingredients	Experimental toothpaste containing fluoride and amino acid (arginine)
fluoride + amino acid in a silica toothpaste	Experimental toothpaste containing fluoride and amino acid (arginine)	Experimental toothpaste containing fluoride and amino acid (arginine)

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 wearing the study 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 (∆ Z).