Effect of Xylitol on Oral Microbiota in Children

Phase 1

Completed

• Conditions: Bacterial Infections
• Interventions: Dietary Supplement: xylitol; Dietary Supplement: sorbitol

• Registration Number: NCT01528969
• Lead Sponsor: Kuwait University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-02-05
• Study First Posted: 2012-02-08
• Study Start: 2012-03
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Results First Submitted: 2015-03-30
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Results First Posted: 2015-08-10
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 122

Inclusion Criteria

• high SM count

Read More

Exclusion Criteria

• low SM count,
• ongoing medication

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xylitol	xylitol	A half of the subjects will be randomly allocated into xylitol group.
Sorbitol	sorbitol	About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day

Primary Outcome Measures

Name	Time	Method
MS Counts of Stimulated Saliva	5 weeks	The MS counts were measured at the beginning and in the end of the 5 weeks intervention

Secondary Outcome Measures

Name	Time	Method
The Changes in the Counts of the 14 Other Bacterial Species	5 weeks	The bacterial species were measured from stimulated saliva at the beginning and after the intervention

Trial Locations

Locations (1)

Faculty of Dentistry, Kuwait University; 🇰🇼 Kuwait, Kuwait