Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model

Dental Caries Clinical Trial

Official title:

Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02708160
• Other study ID #: ERO-2015-CAI-03-RPS
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: February 2019
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 retainer(s)

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. Positive urine test for pregnancy (a urine pregnancy test will be performed on female subjects of child-bearing potential)

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 history to common toothpaste ingredients

13. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Fluoride Free toothpaste
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 1 minute before rinsing with water.
• 1.1% Fluoride toothpaste
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 1 minute before rinsing with water.
• 0.243% Fluoride toothpaste
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 1 minute before rinsing with water.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mineral Change (delta Z)	Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of brushing while wearing the study oral 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)