Text Size

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
History of Changes
  Purpose

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
Dental Caries
 Other: food - novel sweetener
Other: food vehicle blank
Other: food - sweetener, positive control
Other: food - sweetener, negative control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Novel Sweetener on the pH of Dental Plaque.

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Further study details as provided by Cargill:

Primary Outcome Measures:
  • Mean minimum plaque pH during the test period [ Time Frame: 0-60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean area under the pH-versus-time curve (AUC) [ Time Frame: 0-60 min ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739778

Locations
United States, Massachusetts
The Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Cargill
Investigators
Principal Investigator: Max Goodson, DDS, PhD The Forsyth Institute
  More Information

No publications provided

Responsible Party: Max Goodson, DDS, PhD, The Forsyth Institute
ClinicalTrials.gov Identifier: NCT00739778     History of Changes
Other Study ID Numbers: CFIS-08-001
Study First Received: August 20, 2008
Last Updated: December 16, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dental Caries
Dental Plaque
Tooth Demineralization
 Tooth Diseases
Stomatognathic Diseases
Dental Deposits

ClinicalTrials.gov processed this record on May 23, 2013