NCT01528969

Brief Summary

  • 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.
  • 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.
  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

August 10, 2015

Completed
Last Updated

August 10, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

January 24, 2012

Results QC Date

March 30, 2015

Last Update Submit

July 14, 2015

Conditions

Bacterial Infections

Keywords

oral microbiotamutans streptococcixylitol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Changes in the Counts of the 14 Other Bacterial Species

    5 weeks

Study Arms (2)

Xylitol

EXPERIMENTAL

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

Dietary Supplement: xylitol

Sorbitol

ACTIVE COMPARATOR

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

Dietary Supplement: sorbitol

Interventions

xylitolDIETARY_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.

Also known as: Xylitol chewing gum, Sorbitol chewing gum
Xylitol
sorbitolDIETARY_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.

Also known as: Sorbitol chewing gum
Sorbitol

Eligibility Criteria

Age11 Years - 14 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • high SM count

You may not qualify if:

  • low SM count,
  • ongoing medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Kuwait University

Kuwait City, Kuwait

Location

Related 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. doi: 10.1159/000095650.

    PMID: 17063022BACKGROUND

  • 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.

    PMID: 8850581BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Interventions

XylitolSorbitol

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Results Point of Contact

Title
Prof. Eino Honkala
Organization
Kuwait University, Faculty of Dentistry
eino.honkala@hsc.edu.kw
+965 65638938

Study Officials

  • Eino Honkala, PhD

    Faculty of Dentistry, Kuwait University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2012

First Posted

February 8, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

August 10, 2015

Results First Posted

August 10, 2015

Record last verified: 2015-07

Locations

KU(1)