NCT01062633

Brief Summary

This study aims at demonstrating the effect of erythritol and xylitol lozenges on preventing the new caries lesions and the possible remineralization effect of both polyols on incipient caries lesions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
2 years until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 4, 2010

Status Verified

December 1, 2007

Enrollment Period

3.1 years

First QC Date

January 29, 2008

Last Update Submit

February 3, 2010

Conditions

Dental Caries

Keywords

dental cariespreventiondietary supplements

Outcome Measures

Primary Outcomes (1)

  • caries reduction

    3 years

Secondary Outcomes (1)

  • Depression of oral microorganisms

    3 years

Study Arms (3)

A, observation

EXPERIMENTAL

dietary supplement

Dietary Supplement: A, erythritol

B

EXPERIMENTAL

dietary supplement

Dietary Supplement: xylitol

C

EXPERIMENTAL

dietary supplement

Dietary Supplement: C, sorbitol

Interventions

A, erythritolDIETARY_SUPPLEMENT

2,5 g 3 times a day

A, observation
xylitolDIETARY_SUPPLEMENT

2,5 g 3 times a day

B
C, sorbitolDIETARY_SUPPLEMENT

2,5 g 3 times aday

C

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who's parents have signed and returned informed consent form

You may not qualify if:

  • Any eating disorder
  • Refuse to continue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Stomatology, University of Tartu

Tartu, 51003, Estonia

RECRUITING

Related Publications (9)

  • Makinen KK, Saag M, Isotupa KP, Olak J, Nommela R, Soderling E, Makinen PL. Similarity of the effects of erythritol and xylitol on some risk factors of dental caries. Caries Res. 2005 May-Jun;39(3):207-15. doi: 10.1159/000084800.

    PMID: 15914983BACKGROUND

  • Isokangas P, Tiekso J, Alanen P, Makinen KK. Long-term effect of xylitol chewing gum on dental caries. Community Dent Oral Epidemiol. 1989 Aug;17(4):200-3. doi: 10.1111/j.1600-0528.1989.tb00611.x.

    PMID: 2758793BACKGROUND

  • Makinen KK, Bennett CA, Hujoel PP, Isokangas PJ, Isotupa KP, Pape HR Jr, Makinen PL. Xylitol chewing gums and caries rates: a 40-month cohort study. J Dent Res. 1995 Dec;74(12):1904-13. doi: 10.1177/00220345950740121501.

    PMID: 8600188BACKGROUND

  • 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

  • Stsepetova J, Truu J, Runnel R, Nommela R, Saag M, Olak J, Nolvak H, Preem JK, Oopkaup K, Krjutskov K, Honkala E, Honkala S, Makinen K, Makinen PL, Vahlberg T, Vermeiren J, Bosscher D, de Cock P, Mandar R. Impact of polyols on Oral microbiome of Estonian schoolchildren. BMC Oral Health. 2019 Apr 18;19(1):60. doi: 10.1186/s12903-019-0747-z.

    PMID: 30999906DERIVED

  • Falony G, Honkala S, Runnel R, Olak J, Nommela R, Russak S, Saag M, Makinen PL, Makinen K, Vahlberg T, Honkala E. Long-Term Effect of Erythritol on Dental Caries Development during Childhood: A Posttreatment Survival Analysis. Caries Res. 2016;50(6):579-588. doi: 10.1159/000450762. Epub 2016 Nov 3.

    PMID: 27806364DERIVED

  • Honkala S, Runnel R, Saag M, Olak J, Nommela R, Russak S, Makinen PL, Vahlberg T, Falony G, Makinen K, Honkala E. Effect of erythritol and xylitol on dental caries prevention in children. Caries Res. 2014;48(5):482-90. doi: 10.1159/000358399. Epub 2014 May 21.

    PMID: 24852946DERIVED

  • Runnel R, Makinen KK, Honkala S, Olak J, Makinen PL, Nommela R, Vahlberg T, Honkala E, Saag M. Effect of three-year consumption of erythritol, xylitol and sorbitol candies on various plaque and salivary caries-related variables. J Dent. 2013 Dec;41(12):1236-44. doi: 10.1016/j.jdent.2013.09.007. Epub 2013 Oct 3.

    PMID: 24095985DERIVED

  • Runnel R, Honkala S, Honkala E, Olak J, Nommela R, Vahlberg T, Makinen KK, Saag M. Caries experience in the permanent dentition among first- and second-grade schoolchildren in southeastern Estonia. Acta Odontol Scand. 2013 May-Jul;71(3-4):410-5. doi: 10.3109/00016357.2012.690529. Epub 2012 May 21.

    PMID: 22607272DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

ErythritolXylitolSorbitol

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Mare Saag, PhD

    University of Tartu

    PRINCIPAL INVESTIGATOR

  • Eino Honkala, PhD

    University of Turku, Institute of Dentistry

    STUDY DIRECTOR

  • Kauko Mäkinen, PhD

    University of Turku

    STUDY CHAIR

Central Study Contacts

Mare Saag, PhD

CONTACT

+372 7319855mare.saag@ut.ee

Rita Nommela, PhD

CONTACT

+372 7319860rita.nommela@ut.ee

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 4, 2010

Study Start

January 1, 2008

Primary Completion

February 1, 2011

Study Completion

November 1, 2011

Last Updated

February 4, 2010

Record last verified: 2007-12

Locations

ES(1)