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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: food - novel sweetener; Other: food vehicle blank; Other: food - sweetener, positive control; Other: food - sweetener, negative control

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • The Forsyth Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean minimum plaque pH during the test period	0-60 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean area under the pH-versus-time curve (AUC)	0-60 min

Collaborators and Investigators

• Sponsor: Cargill
• Investigators: Principal Investigator: Max Goodson, DDS, PhD, The Forsyth Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 20, 2008
• First Submitted That Met QC Criteria: August 21, 2008
• First Posted (Estimate): August 22, 2008

Study Record Updates

• Last Update Posted (Estimate): December 18, 2008
• Last Update Submitted That Met QC Criteria: December 16, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Deposits; Dental Caries; Dental Plaque
• Other Study ID Numbers: CFIS-08-001