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Sponsored by: |
Cargill |
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Information provided by: | Cargill |
ClinicalTrials.gov Identifier: | NCT00739778 |
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.
Condition | Intervention | Phase |
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Dental Caries |
Other: food - novel sweetener Other: food vehicle blank Other: food - sweetener, positive control Other: food - sweetener, negative control |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effect of a Novel Sweetener on the pH of Dental Plaque. |
Estimated Enrollment: | 24 |
Study Start Date: | August 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The Forsyth Institute ( Max Goodson, DDS, PhD ) |
Study ID Numbers: | CFIS-08-001 |
Study First Received: | August 20, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00739778 History of Changes |
Health Authority: | United States: Institutional Review Board |
Tooth Diseases Stomatognathic Diseases Dental Plaque Dental Caries |
Tooth Diseases Dental Deposits Stomatognathic Diseases |
Tooth Demineralization Dental Plaque Dental Caries |