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

NCT02388178 | Withdrawn Phase 2

• 1 other identifier: ERO-2014-CAI-02-RPS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

Fluoride free, silica based toothpaste

PLACEBO COMPARATOR

Control toothpaste containing no anti-cavity ingredients

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

Experimental toothpaste containing fluoride and amino acid (arginine)

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

Fluoride toothpaste containing fluoride as the anti-cavity ingredient

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

Interventions

Control toothpaste containing no anti-cavity ingredients DRUG

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.

Also known as: Fluoride free toothpaste control

1450 ppm fluoride in a silica base toothpaste; Fluoride free, silica based toothpaste; fluoride + amino acid in a silica toothpaste

Experimental toothpaste containing fluoride and amino acid (arginine) DRUG

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.

Also known as: Experimental toothpaste

1450 ppm fluoride in a silica base toothpaste; Fluoride free, silica based toothpaste; fluoride + amino acid in a silica toothpaste

Fluoride toothpaste containing fluoride as the anti-cavity ingredient DRUG

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.

Also known as: Fluoride only toothpaste control

1450 ppm fluoride in a silica base toothpaste; Fluoride free, silica based toothpaste; fluoride + amino acid in a silica toothpaste

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and/or female subjects 18 to 50 years inclusive
• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
• Willing to wear retainer 24 hours per day
• No active, unrestored cavities
• 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
• Available throughout entire study
• Willing to use only assigned products for oral hygiene throughout the duration of the study
• Must give written informed consent
• Must be in good general health
• 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

You may not qualify if:

• Advanced periodontal disease
• Medical condition which requires premedication prior to dental visits/procedures
• Not enough teeth to secure the oral retainer
• Diseases of the soft or hard oral tissues
• Wear an Orthodontic appliances
• Impaired salivary function
• Current use drugs that can affect salivary flow
• Use antibiotics one (1) month prior to or during this study
• Pregnant or breastfeeding
• Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
• Use tobacco products
• Allergic to common toothpaste ingredients
• Allergic to amino acids
• Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)

Sponsors & Collaborators

• Colgate Palmolive: lead

MeSH Terms

Conditions

Dental Caries

Interventions

Amino Acids; Arginine

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Amino Acids, Basic; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Bennet Amaechi, PhD, DDS

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: March 13, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 27, 2022

Record last verified: 2022-09