Effect of Xylitol on Oral Microbiota in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Dietary supplement: xylitol; Dietary supplement: sorbitol

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • Faculty of Dentistry, Kuwait University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• high SM count

Exclusion Criteria:

• low SM count,
• ongoing medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xylitol; A half of the subjects will be randomly allocated into xylitol group.	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.; Other Names: Xylitol chewing gum; Sorbitol chewing gum
Active Comparator: Sorbitol; About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day	Dietary supplement: 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.; Other Names: Sorbitol chewing gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MS Counts of Stimulated Saliva	The MS counts were measured at the beginning and in the end of the 5 weeks intervention	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kuwait University
• Collaborators: University of Turku; University of Michigan
• Investigators: Principal Investigator: Eino Honkala, PhD, Faculty of Dentistry, Kuwait University

Publications and helpful links

General Publications

• 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. doi: 10.1159/000095650.
• Honkala E, Rimpela A, Karvonen S, Rimpela M. Chewing of xylitol gum--a well adopted practice among finnish adolescents. Caries Res. 1996;30(1):34-9. doi: 10.1159/000262134.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: February 5, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 10, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: xylitol; mutans streptococci; oral microbiota
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Gastrointestinal Agents; Cathartics; Sorbitol
• Other Study ID Numbers: DD02/10; KU-DD02/10 (Other Grant/Funding Number: Kuwait University)