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Tracking Information | |||||
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First Received Date † | August 20, 2008 | ||||
Last Updated Date | December 16, 2008 | ||||
Start Date † | August 2008 | ||||
Current Primary Outcome Measures † |
Mean minimum plaque pH during the test period [ Time Frame: 0-60 minutes ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00739778 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Mean area under the pH-versus-time curve (AUC) [ Time Frame: 0-60 min ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Effect of a Novel Sweetener on the pH of Dental Plaque. | ||||
Official Title † | Effect of a Novel Sweetener on the pH of Dental Plaque. | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||
Condition † | Dental Caries | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 24 | ||||
Completion Date | December 2008 | ||||
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00739778 | ||||
Responsible Party | Max Goodson, DDS, PhD, The Forsyth Institute | ||||
Secondary IDs †† | |||||
Study Sponsor † | Cargill | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Cargill | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |