Trial Outcomes & Findings for Xylitol for Caries Prevention in Inner-City Children (NCT NCT01901250)
NCT ID: NCT01901250
Last Updated: 2014-08-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
562 participants
Primary outcome timeframe
baseline and middle of 2nd grade
Results posted on
2014-08-12
Participant Flow
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).
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
260
|
265
|
|
Overall Study
End of Kidergarten
|
215
|
212
|
|
Overall Study
Start of 1st Grade
|
173
|
176
|
|
Overall Study
End of 1st Grade
|
143
|
151
|
|
Overall Study
COMPLETED
|
122
|
139
|
|
Overall Study
NOT COMPLETED
|
138
|
126
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Xylitol for Caries Prevention in Inner-City Children
Baseline characteristics by cohort
| Measure |
Xylitol GB
n=260 Participants
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.
|
Fiber GB
n=265 Participants
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.
|
Total
n=525 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
260 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
525 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
227 participants
n=5 Participants
|
234 participants
n=7 Participants
|
461 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not reported
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Overall Caries Burden at Baseline
None (0 dmfs/DMFS)
|
112 participants
n=5 Participants
|
138 participants
n=7 Participants
|
250 participants
n=5 Participants
|
|
Overall Caries Burden at Baseline
Moderate (1-5 dmfs/DMFS)
|
68 participants
n=5 Participants
|
66 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Overall Caries Burden at Baseline
Severe (6 or more dmfs/DMFS)
|
80 participants
n=5 Participants
|
61 participants
n=7 Participants
|
141 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and middle of 2nd gradeThe 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.
Outcome measures
| Measure |
Xylitol GB
n=122 Participants
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.
|
Fiber GB
n=139 Participants
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.
|
|---|---|---|
|
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
|
0.48 Number of surfaces
Standard Deviation 1.39
|
Adverse Events
Xylitol GB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fiber GB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place