Effect of Xylitol on Oral Microbiota in Children

NCT ID: NCT01528969

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-05-31

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.

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Xylitol

A half of the subjects will be randomly allocated into xylitol group.

Group Type: EXPERIMENTAL

xylitol

Intervention Type: DIETARY_SUPPLEMENT

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

About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day

Group Type: ACTIVE_COMPARATOR

sorbitol

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Xylitol chewing gum; Sorbitol chewing gum; Sorbitol chewing gum

Eligibility Criteria

Inclusion Criteria

• high SM count

Exclusion Criteria

• low SM count,
• ongoing medication

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Kuwait University

OTHER

Sponsor Role: lead

Responsible Party

Eino Honkala

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eino Honkala, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Kuwait University

Locations

Faculty of Dentistry, Kuwait University

Kuwait City, , Kuwait

Countries

Kuwait

References

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.

Reference Type: BACKGROUND

PMID: 17063022 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8850581 (View on PubMed)

Other Identifiers

KU-DD02/10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DD02/10

Identifier Type: -

Identifier Source: org_study_id