Trial Outcomes & Findings for Effect of Xylitol on Oral Microbiota in Children (NCT NCT01528969)
NCT ID: NCT01528969
Last Updated: 2015-08-10
Results Overview
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
122 participants
Primary outcome timeframe
5 weeks
Results posted on
2015-08-10
Participant Flow
Altogether 122 10-12-year-old boys, whose parents gave a positive consent, participated in the baseline examinations. The study was conducted at one school in Jabriya, Kuwait.
Str mutans was measured from plaque and saliva. Those children who had high mutans counts (n=75) were included into the intervention.
Participant milestones
| Measure |
Xylitol
A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks.
|
Sorbitol
A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
|
Overall Study
COMPLETED
|
35
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Xylitol
A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks.
|
Sorbitol
A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks.
|
|---|---|---|
|
Overall Study
absent from the school at baseline
|
2
|
0
|
Baseline Characteristics
Effect of Xylitol on Oral Microbiota in Children
Baseline characteristics by cohort
| Measure |
Xylitol
n=37 Participants
A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.
|
Sorbitol
n=38 Participants
A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.5 years
n=5 Participants
|
11.5 years
n=7 Participants
|
11.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Kuwait
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Nationality of subjects
Kuwaiti
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Nationality of subjects
non-Kuwaiti Arab
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 weeksThe MS counts were measured at the beginning and in the end of the 5 weeks intervention
Outcome measures
| Measure |
Xylitol
n=35 Participants
A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.
|
Sorbitol
n=38 Participants
A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.
|
|---|---|---|
|
MS Counts of Stimulated Saliva
Baseline
|
4.86 MS counts log CFU/ml
Standard Deviation 1.34
|
4.40 MS counts log CFU/ml
Standard Deviation 1.71
|
|
MS Counts of Stimulated Saliva
5-week follow-up
|
4.29 MS counts log CFU/ml
Standard Deviation 1.73
|
3.78 MS counts log CFU/ml
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: 5 weeksThe bacterial species were measured from stimulated saliva at the beginning and after the intervention
Outcome measures
Outcome data not reported
Adverse Events
Xylitol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sorbitol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Xylitol
n=35 participants at risk
A half of the subjects (n = 37) were randomly allocated into xylitol group.
Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.
None of the subjects had any adverse effects of the consumption of the chewing gum.
|
Sorbitol
n=38 participants at risk
A half of the subjects (n = 38) were randomly allocated into sorbitol group.
Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.
None of the subjects had any adverse effects of the consumption of the chewing gum.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/35 • during the 1st week after the intervention was concluded.
Subjects were interviewed about the possible side-effects (e.g. diarrhea) after the five-weeks intervention in the connection of the follow-up examinations.
|
0.00%
0/38 • during the 1st week after the intervention was concluded.
Subjects were interviewed about the possible side-effects (e.g. diarrhea) after the five-weeks intervention in the connection of the follow-up examinations.
|
Additional Information
Prof. Eino Honkala
Kuwait University, Faculty of Dentistry
Phone: +965 65638938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place