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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739778
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : December 18, 2008
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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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Novel Sweetener on the pH of Dental Plaque.
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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

Primary Outcome Measures :
  1. Mean minimum plaque pH during the test period [ Time Frame: 0-60 minutes ]

Secondary Outcome Measures :
  1. Mean area under the pH-versus-time curve (AUC) [ Time Frame: 0-60 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739778

United States, Massachusetts
The Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Principal Investigator: Max Goodson, DDS, PhD The Forsyth Institute

Responsible Party: Max Goodson, DDS, PhD, The Forsyth Institute Identifier: NCT00739778     History of Changes
Other Study ID Numbers: CFIS-08-001
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008

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