Effect of a Novel Sweetener on the pH of Dental Plaque. - Full Text View

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 II

ChemIDplus related topics:

Sucrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Official Title:	Effect of a Novel Sweetener on the pH of Dental Plaque.

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

concentration to be isosweet with 4.7% sucrose

water blank

4.7% sucrose in water

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

Contacts


Contact: MaryAnn Cugini, RDH, MHP	617-892-8462	mcugini@forsyth.org

Locations


United States, Massachusetts
	The Forsyth Institute	Recruiting
	Boston, Massachusetts, United States, 02115
	Contact: MaryAnn Cugini, RDH, MHP 617-892-8462 mcugini@forsyth.org
	Principal Investigator: Max Goodson, DDS, PhD

Sponsors and Collaborators

Cargill

Investigators


Principal Investigator:	Max Goodson, DDS, PhD	The Forsyth Institute

More Information

Responsible Party:	The Forsyth Institute ( Max Goodson, DDS, PhD )
Study ID Numbers:	CFIS-08-001
First Received:	August 20, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00739778
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Tooth Diseases

Stomatognathic Diseases

Dental Plaque

Dental Caries

Additional relevant MeSH terms:

Dental Deposits

Tooth Demineralization

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Cargill
Information provided by:	Cargill
ClinicalTrials.gov Identifier:	NCT00739778