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Effect of Xylitol on Oral Microbiota in Children

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ClinicalTrials.gov Identifier: NCT01528969
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborators:
University of Turku
University of Michigan
Information provided by (Responsible Party):
Eino Honkala, Kuwait University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Bacterial Infections
Interventions Dietary Supplement: xylitol
Dietary Supplement: sorbitol
Enrollment 122
Recruitment Details 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.
Pre-assignment Details Str mutans was measured from plaque and saliva. Those children who had high mutans counts (n=75) were included into the intervention.
Arm/Group Title Xylitol Sorbitol
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 37 38
Completed 35 38
Not Completed 2 0
Reason Not Completed
absent from the school at baseline             2             0
Arm/Group Title Xylitol Sorbitol Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 37 38 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 38 participants 75 participants
11.5
(10 to 12)
11.5
(10 to 12)
11.5
(10 to 12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
37
 100.0%
38
 100.0%
75
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
37
 100.0%
38
 100.0%
75
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
37
 100.0%
38
 100.0%
75
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Kuwait Number Analyzed 37 participants 38 participants 75 participants
37 38 75
Nationality of subjects  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Kuwaiti 36 37 73
non-Kuwaiti Arab 1 1 2
1.Primary Outcome
Title MS Counts of Stimulated Saliva
Hide Description The MS counts were measured at the beginning and in the end of the 5 weeks intervention
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xylitol Sorbitol
Hide Arm/Group Description:

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.

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%.

Overall Number of Participants Analyzed 35 38
Mean (Standard Deviation)
Unit of Measure: MS counts log CFU/ml
Baseline 4.86  (1.34) 4.40  (1.71)
5-week follow-up 4.29  (1.73) 3.78  (1.83)
2.Secondary Outcome
Title The Changes in the Counts of the 14 Other Bacterial Species
Hide Description The bacterial species were measured from stimulated saliva at the beginning and after the intervention
Time Frame 5 weeks
Outcome Measure Data Not Reported
Time Frame during the 1st week after the intervention was concluded.
Adverse Event Reporting Description Subjects were interviewed about the possible side-effects (e.g. diarrhea) after the five-weeks intervention in the connection of the follow-up examinations.
 
Arm/Group Title Xylitol Sorbitol
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Xylitol Sorbitol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Xylitol Sorbitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Xylitol Sorbitol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/38 (0.00%)    
Gastrointestinal disorders     
Diarrhea  [1]  0/35 (0.00%)  0 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Interview after the intervention
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Eino Honkala
Organization: Kuwait University, Faculty of Dentistry
Phone: +965 65638938
EMail: eino.honkala@hsc.edu.kw
Layout table for additonal information
Responsible Party: Eino Honkala, Kuwait University
ClinicalTrials.gov Identifier: NCT01528969     History of Changes
Other Study ID Numbers: DD02/10
KU-DD02/10 ( Other Grant/Funding Number: Kuwait University )
First Submitted: January 24, 2012
First Posted: February 8, 2012
Results First Submitted: March 30, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015