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

This study has been completed.
Sponsor:
Information provided by:
Cargill
ClinicalTrials.gov Identifier:
NCT00739778
First received: August 20, 2008
Last updated: December 16, 2008
Last verified: December 2008

August 20, 2008
December 16, 2008
August 2008
December 2008   (final data collection date for primary outcome measure)
Mean minimum plaque pH during the test period [ Time Frame: 0-60 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739778 on ClinicalTrials.gov Archive Site
Mean area under the pH-versus-time curve (AUC) [ Time Frame: 0-60 min ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of a Novel Sweetener on the pH of Dental Plaque.
Effect of a Novel Sweetener on the pH of Dental Plaque.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Dental Caries
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739778
CFIS-08-001
No
Max Goodson, DDS, PhD, The Forsyth Institute
Cargill
Not Provided
Principal Investigator: Max Goodson, DDS, PhD The Forsyth Institute
Cargill
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP