To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study
NCT ID: NCT02388178
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2015-04-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Fluoride free, silica based toothpaste
Control toothpaste containing no anti-cavity ingredients
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.
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.
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.
fluoride + amino acid in a silica toothpaste
Experimental toothpaste containing fluoride and amino acid (arginine)
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.
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.
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.
1450 ppm fluoride in a silica base toothpaste
Fluoride toothpaste containing fluoride as the anti-cavity ingredient
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
50 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Principal Investigators
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Bennet Amaechi, PhD, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Other Identifiers
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ERO-2014-CAI-02-RPS
Identifier Type: -
Identifier Source: org_study_id
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