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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739778
• Other study ID #: CFIS-08-001
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: December 16, 2008
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Cargill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries
• Dental Plaque

Intervention

Other:
• food - novel sweetener
concentration to be isosweet with 4.7% sucrose
• food vehicle blank
water blank
• food - sweetener, positive control
4.7% sucrose in water
• food - sweetener, negative control
non-cariogenic sweetener at concentration isosweet with 4.7% sucrose

Locations

Country	Name	City	State
United States	The Forsyth Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cargill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean minimum plaque pH during the test period		0-60 minutes	No
Secondary	Mean area under the pH-versus-time curve (AUC)		0-60 min	No