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

Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.

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• Status: Withdrawn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: Dental Caries
• Intervention / 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

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Fluoride free, silica based toothpaste; Control toothpaste containing no anti-cavity ingredients	Drug: Control toothpaste containing no anti-cavity ingredients; 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 for 1 minute before rinsing with water.; Other Names: Fluoride free toothpaste control; Drug: Experimental toothpaste containing fluoride and amino acid (arginine); 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 for 1 minute before rinsing with water.; Other Names: Experimental toothpaste; Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient; 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 for 1 minute before rinsing with water.; Other Names: Fluoride only toothpaste control
Experimental: fluoride + amino acid in a silica toothpaste; Experimental toothpaste containing fluoride and amino acid (arginine)	Drug: Control toothpaste containing no anti-cavity ingredients; 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 for 1 minute before rinsing with water.; Other Names: Fluoride free toothpaste control; Drug: Experimental toothpaste containing fluoride and amino acid (arginine); 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 for 1 minute before rinsing with water.; Other Names: Experimental toothpaste; Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient; 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 for 1 minute before rinsing with water.; Other Names: Fluoride only toothpaste control
Active Comparator: 1450 ppm fluoride in a silica base toothpaste; Fluoride toothpaste containing fluoride as the anti-cavity ingredient	Drug: Control toothpaste containing no anti-cavity ingredients; 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 for 1 minute before rinsing with water.; Other Names: Fluoride free toothpaste control; Drug: Experimental toothpaste containing fluoride and amino acid (arginine); 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 for 1 minute before rinsing with water.; Other Names: Experimental toothpaste; Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient; 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 for 1 minute before rinsing with water.; Other Names: Fluoride only toothpaste control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mineral Change (delta Z)	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 (∆ Z).	Baseline
Mineral Change (delta Z)	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).	2 weeks (from Baseline)

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Bennet Amaechi, PhD, DDS, University of Texas

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: ERO-2014-CAI-02-RPS