Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.

Official Title
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Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Toothpaste containing 1150ppm F
* Other: Toothpaste containing 0ppm F
* Drug: Toothpaste containing 250ppm F
* Drug: Toothpaste containing 1150ppm F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Demonstrates understanding of the study. Aged 18 to 85 years. Understands and is willing, able and likely to comply with all study procedures and restrictions. Has good general health (in the opinion of the investigator or medically qualified designee). Currently living in the Indianapolis, Indiana area. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens. Have no current active caries or periodontal disease and all restorations in a good state of repair. Have a salivary flow rate in the range of normal values. Exclusion Criteria: Pregnant or breast feeding women. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. Have received a professional fluoride treatment within 14 days of randomization to the first treatment. Recent history (within the last year) of alcohol or other substance abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test fluoride toothpaste<br>Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods | Drug: Toothpaste containing 1150ppm F<br>* US marketed toothpaste containing 1150ppm of F<br>|
| Placebo Comparator: Fluoride free (0ppm F) reference control toothpaste<br>Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. | Other: Toothpaste containing 0ppm F<br>* Experimental toothpaste containing 0ppm F<br>|
| Active Comparator: Low dose fluoride (250ppm F) reference control toothpaste<br>Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. | Drug: Toothpaste containing 250ppm F<br>* Experimental toothpaste containing 250ppm F<br>|
| Active Comparator: Fluoride (1150ppm F) reference control toothpaste<br>Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. | Drug: Toothpaste containing 1150ppm F<br>* Experimental toothpaste containing 1150ppm F<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste | The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments | The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ) | 4 weeks | 
| Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments | The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth) | 4 weeks | 
| Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments | The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax) | 4 weeks |