Back to resultsEffect of a Novel Sweetener on the pH of Dental Plaque.
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
food - novel sweetener
food vehicle blank
food - sweetener, positive control
food - sweetener, negative control
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
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.
Sites / Locations
- The Forsyth Institute
Outcomes
Primary Outcome Measures
Mean minimum plaque pH during the test period
Secondary Outcome Measures
Mean area under the pH-versus-time curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00739778
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cargill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
food - novel sweetener
Intervention Description
concentration to be isosweet with 4.7% sucrose
Intervention Type
Other
Intervention Name(s)
food vehicle blank
Intervention Description
water blank
Intervention Type
Other
Intervention Name(s)
food - sweetener, positive control
Intervention Description
4.7% sucrose in water
Intervention Type
Other
Intervention Name(s)
food - sweetener, negative control
Intervention Description
non-cariogenic sweetener at concentration isosweet with 4.7% sucrose
Primary Outcome Measure Information:
Title
Mean minimum plaque pH during the test period
Time Frame
0-60 minutes
Secondary Outcome Measure Information:
Title
Mean area under the pH-versus-time curve (AUC)
Time Frame
0-60 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Goodson, DDS, PhD
Organizational Affiliation
The Forsyth Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Forsyth Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Effect of a Novel Sweetener on the pH of Dental Plaque.
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