Dental Caries
Conditions
Keywords
Dental Caries, Xylitol, 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.
Interventions
DIETARY_SUPPLEMENTXylitol gummy bears
The children receive xylitol gummy bears 3 times/day within the supervised school environment.
DIETARY_SUPPLEMENTSugar free fiber gummy bears
The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
BEHAVIORALOral health education
Oral health education, toothbrush, and fluoride toothpaste
DEVICEFluoride varnish
The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
DEVICEDental sealant
The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.
Sponsors
Health Resources and Services Administration (HRSA)
University of Washington
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade | baseline and middle of 2nd grade | The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces. For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the D and F portions of DFT, respectively. |
Countries
United States
Participant flow
Recruitment details
Three cohorts of kindergarten children were recruited from 5 elementary schools between 2007 and 2009. A total of 32 classrooms were randomized to xylitol (16 classrooms) and placebo (16 classrooms).
Pre-assignment details
Out of 562 children recruited, a total of 37 children did not have the baseline dental examination (13 children were transferred out of school district and 24 children were absent from the baseline dental examination).
Participants by arm
| Arm | Count |
|---|---|
| Xylitol GB Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted. | 260 |
| Fiber GB Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
Oral health education: Oral health education, toothbrush, and fluoride toothpaste
Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted. | 265 |
| Total | 525 |
Baseline characteristics
| Characteristic | Xylitol GB | Fiber GB | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 260 Participants | 265 Participants | 525 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Overall Caries Burden at Baseline Moderate (1-5 dmfs/DMFS) | 68 participants | 66 participants | 134 participants |
| Overall Caries Burden at Baseline None (0 dmfs/DMFS) | 112 participants | 138 participants | 250 participants |
| Overall Caries Burden at Baseline Severe (6 or more dmfs/DMFS) | 80 participants | 61 participants | 141 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black Non-Hispanic | 227 participants | 234 participants | 461 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Unknown or Not reported | 27 participants | 26 participants | 53 participants |
| Race/Ethnicity, Customized White Non-Hispanic | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 143 Participants | 137 Participants | 280 Participants |
| Sex: Female, Male Male | 117 Participants | 128 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 260 | 0 / 265 |
| serious Total, serious adverse events | 0 / 260 | 0 / 265 |
Outcome results
Primary
Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade
The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces. For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the D and F portions of DFT, respectively.
Time frame: baseline and middle of 2nd grade
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xylitol GB | Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade | 0.38 Number of surfaces | Standard Deviation 0.88 |
| Fiber GB | Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade | 0.48 Number of surfaces | Standard Deviation 1.39 |
p-value: 0.25Permutation test