Effect of a Novel Sweetener on the pH of Dental Plaque.

Study Overview
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Brief Summary
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Bacteria that live in the mouth can digest fermentable carbohydrates such as sucrose, fructose, and glucose to make acid. This acid can cause demineralization of the tooth and lead to dental caries or decay. Noncariogenic carbohydrate sweeteners, such as sugar alcohols, can be used to replace fermentable carbohydrates in foods, thereby decreasing the risk of caries. In order for a sweetener to be labeled as a noncariogenic sweetener, the FDA requires that when present in food, the food should not lower the dental plaque pH below 5.7 either during or up to 30 minutes after consumption. The purpose of this study is to determine whether a new developmental sweetener can be fermented by the bacteria in the mouth and lead to acid production. This will be done by measuring the pH of dental plaque following consumption of the sweetener.

Official Title
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Effect of a Novel Sweetener on the pH of Dental Plaque.

Conditions
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Dental Caries

Intervention / Treatment
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* Other: food - novel sweetener
* Other: food vehicle blank
* Other: food - sweetener, positive control
* Other: food - sweetener, negative control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health as evidenced by the medical history. Male or non-pregnant, non-lactating females ages 18 to 75 inclusive. Caries experience in the past year. More than 5 decayed, missing, or filled teeth demonstrating a high caries experience. Acidogenic plaque as demonstrated by a drop in pH to 5.7 or lower when challenged with sucrose rinse at the screening visit. Willing to abstain from all oral hygiene procedures, brushing and flossing, for 48 hours prior to each test day and drink only water for the four (4) hours prior to each test. Willing to abstain from the use of mouthwashes during the study. Exclusion Criteria: Presence of orthodontic appliances. Systemic conditions which could influence the pH of the oral cavity (i.e., diabetes, salivary gland disorders etc.). Use of medications that would influence the pH of the oral cavity. Specifically, concomitant use of neuroleptics, atropine, chemotherapeutic agents, diuretics, antibiotics, antihistamines, decongestants, and muscle relaxants. Also, anticipated need for intermittent use of any medications in these classes or history of use during the 72 hours immediately prior to the screening visit. Patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of Investigator. Females who by self report are pregnant, lactating, planning to be pregnant during the study period, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception during the study period. Exposure to any investigational agent within the 30 days prior to study visit 1 Individuals requiring prophylactic antibiotics Allergy or intolerance to food ingredients and products including artificial sweeteners.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: food - novel sweetener|concentration to be isosweet with 4.7% sucrose|
|Other: food vehicle blank|water blank|
|Other: food - sweetener, positive control|4.7% sucrose in water|
|Other: food - sweetener, negative control|non-cariogenic sweetener at concentration isosweet with 4.7% sucrose|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean minimum plaque pH during the test period |  | 0-60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area under the pH-versus-time curve (AUC) |  | 0-60 min |