Effect of Xylitol on Oral Microbiota in Children

Bacterial Infections Clinical Trial

Official title:

The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528969
• Other study ID #: DD02/10
• Secondary ID: KU-DD02/10
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 24, 2012
• Last updated: July 14, 2015
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: July 2015
• Source: Kuwait University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kuwait: Joint Committee for the Protection of Human Subjects in Research
• Study type: Interventional

Clinical Trial Summary

1. The present controlled, randomized, doubleblind study aims to answer the following questions:

• How will the "normal flora" be affected by the xylitol consumption?

• Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?

• The association of the test results will also be compared with the caries status at the baseline.

2. About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.

3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.

4. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.

Description:

Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.

The present controlled, randomized, doubleblind study aims to answer the following questions:

1. How will the "normal flora" be affected by the xylitol consumption?

2. Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?

3. The association of the test results will also be compared with the caries status at the baseline.

After collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).

Sorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• high SM count

Exclusion Criteria:

• low SM count,

• ongoing medication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Dietary Supplement:
• xylitol
Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day in the experimental group for a five-week period.
• sorbitol
Subjects will chew 2 pieces of sorbitol chewing gum (1,5 g/pellet) three times a day in the control group for a five-week period.

Locations

Country	Name	City	State
Kuwait	Faculty of Dentistry, Kuwait University	Kuwait

Sponsors (3)

Lead Sponsor	Collaborator
Kuwait University	University of Michigan, University of Turku

Country where clinical trial is conducted

Kuwait, 

References & Publications (2)

Honkala E, Honkala S, Shyama M, Al-Mutawa SA. Field trial on caries prevention with xylitol candies among disabled school students. Caries Res. 2006;40(6):508-13. — View Citation

Honkala E, Rimpelä A, Karvonen S, Rimpelä M. Chewing of xylitol gum--a well adopted practice among finnish adolescents. Caries Res. 1996;30(1):34-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MS Counts of Stimulated Saliva	The MS counts were measured at the beginning and in the end of the 5 weeks intervention	5 weeks	No
Secondary	The Changes in the Counts of the 14 Other Bacterial Species	The bacterial species were measured from stimulated saliva at the beginning and after the intervention	5 weeks	No