Clinical trial NCT01901250: Xylitol for Caries Prevention in Inner-City Children
Official title: Xylitol for Caries Prevention in Inner-City Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Dental Caries
Xylitol
Prevention
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: University of Washington
First posted: 2013-07-17
Enrollment: 562
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.

Detailed description: This is a two group, 30 month randomized controlled clinical trial to assess, in conjunction with other primary preventive modalities, the use of xylitol gummy bears as snack food during school hours to reduce dental caries among children attending Kindergarten at the time of recruitment.

Classrooms in five elementary schools were randomized to receive xylitol gummy bears or the control sugar-free (fiber) gummy bears. All gummy bears were formulated to be similar in size, consistency, color, and sweetness. They were in six bright colors attractive to children, and in strawberry and cherry flavors which are popular among children. Children were encouraged to chew the gummy bears slowly to maximize the xylitol exposure time in the mouth. The children received xylitol or placebo gummy bears throughout the 9 month kindergarten year, 3 times/day within the supervised school environment.

In addition to gummy bears, all participating children received oral health education, tooth brushing and fluoridated toothpaste, topical fluoride varnish treatment, and dental sealants when the first permanent molars have completely erupted. This design allows for the comparison between the current best recommended public heath practices and the addition of the new strategy, xylitol gummy bear snacks. Children were enrolled in kindergarten and followed until the middle of 2nd grade.

Eligibility criteria: Inclusion Criteria:

* attending kindergarten in one of the participating schools
* must have parental permission

Exclusion Criteria:

* children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.)
* children with strict dietary restriction (ex. Diabetes)

Primary outcomes:
measure: Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade
timeFrame: baseline and middle of 2nd grade
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Suchitra Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson S, Eggertsson H, Powell B, Mandelaris J, Ntragatakis M, Richardson T, Ferretti G. Dental examiners consistency in applying the ICDAS criteria for a caries prevention community trial. Community Dent Health. 2011 Sep;28(3):238-42.
citation: Nelson S, Milgrom P. Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States. Contemp Clin Trials. 2012 Jan;33(1):60-6. doi: 10.1016/j.cct.2011.09.012. Epub 2011 Oct 1.
citation: Nelson S, Mandelaris J, Ferretti G, Heima M, Spiekerman C, Milgrom P. School screening and parental reminders in increasing dental care for children in need: a retrospective cohort study. J Public Health Dent. 2012 Winter;72(1):45-52. doi: 10.1111/j.1752-7325.2011.00282.x. Epub 2011 Oct 10.