Effect of Erythritol and Xylitol on Dental Caries Prevention in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2007 by University of Tartu.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01062633

First Posted: February 4, 2010

Last Update Posted: February 4, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

University of Turku

Information provided by:

University of Tartu

Purpose

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.

Condition	Intervention	Phase
Dental Caries	Dietary Supplement: A, erythritol Dietary Supplement: xylitol Dietary Supplement: C, sorbitol	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Effect of Erythritol and Xylitol on Dental Caries Prevention in Children

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay

Drug Information available for: Xylitol

U.S. FDA Resources

Further study details as provided by University of Tartu:

Primary Outcome Measures:

caries reduction [ Time Frame: 3 years ]

Secondary Outcome Measures:

Depression of oral microorganisms [ Time Frame: 3 years ]


Estimated Enrollment:	450
Study Start Date:	January 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A, observation dietary supplement	Dietary Supplement: A, erythritol 2,5 g 3 times a day
Experimental: B dietary supplement	Dietary Supplement: xylitol 2,5 g 3 times a day
Experimental: C dietary supplement	Dietary Supplement: C, sorbitol 2,5 g 3 times aday

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Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	7 Years to 9 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any eating disorder
Refuse to continue

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062633

Contacts


Contact: Mare Saag, PhD	+372 7319855	mare.saag@ut.ee
Contact: Rita Nommela, PhD	+372 7319860	rita.nommela@ut.ee

Locations


Estonia
Department of Stomatology, University of Tartu	Recruiting
Tartu, Estonia, 51003
Contact: Mare Saag, PhD +372 7 319 855 mare.saag@ut.ee
Contact: Rita Nommela, PhD +372 7 319 860 rita.nommela@ut.ee
Sub-Investigator: Jana Olak, DDS
Sub-Investigator: Riina Runnel, DDS
Sub-Investigator: Pirkko-Liisa Makinen, PhD
Sub-Investigator: Sisko Honkala, PhD
Sub-Investigator: Rita Nommela, PhD
Sub-Investigator: Silvia Russsak, PhD

Sponsors and Collaborators

University of Tartu

University of Turku

Investigators


Principal Investigator:	Mare Saag, PhD	University of Tartu
Study Director:	Eino Honkala, PhD	University of Turku, Institute of Dentistry
Study Chair:	Kauko Mäkinen, PhD	University of Turku

More Information

Publications:

Mäkinen KK, Saag M, Isotupa KP, Olak J, Nõmmela R, Söderling E, Mäkinen 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.

Isokangas P, Tiekso J, Alanen P, Mäkinen KK. Long-term effect of xylitol chewing gum on dental caries. Community Dent Oral Epidemiol. 1989 Aug;17(4):200-3.

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Honkala S, Runnel R, Saag M, Olak J, Nõmmela R, Russak S, Mäkinen PL, Vahlberg T, Falony G, Mäkinen 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.

Runnel R, Mäkinen KK, Honkala S, Olak J, Mäkinen PL, Nõmmela 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.

Runnel R, Honkala S, Honkala E, Olak J, Nõmmela R, Vahlberg T, Mäkinen 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.


Responsible Party:	Mare Saag prof, University of Tartu
ClinicalTrials.gov Identifier:	NCT01062633 History of Changes
Other Study ID Numbers:	N012/95 VARST 07264 2008-2011
First Submitted:	January 29, 2008
First Posted:	February 4, 2010
Last Update Posted:	February 4, 2010
Last Verified:	December 2007

Keywords provided by University of Tartu:


dental caries prevention dietary supplements

Additional relevant MeSH terms:


Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Sorbitol	Erythritol Cathartics Gastrointestinal Agents Vasodilator Agents

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