Status:
COMPLETED
Effect of a Novel Sweetener on the pH of Dental Plaque.
Lead Sponsor:
Cargill
Conditions:
Dental Caries
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00739778
Start Date
August 1 2008
End Date
December 1 2008
Last Update
December 18 2008
Active Locations (1)
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1
The Forsyth Institute
Boston, Massachusetts, United States, 02115