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Effect of Erythritol and Xylitol on Dental Caries Prevention in Children

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. Identifier: NCT01062633
Recruitment Status : Unknown
Verified December 2007 by University of Tartu.
Recruitment status was:  Recruiting
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
University of Turku
Information provided by:
University of Tartu

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
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
Study Start Date : January 2008
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Xylitol

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. caries reduction [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Depression of oral microorganisms [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Any eating disorder
  • Refuse to continue

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 identifier (NCT number): NCT01062633

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Contact: Mare Saag, PhD +372 7319855
Contact: Rita Nommela, PhD +372 7319860

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Department of Stomatology, University of Tartu Recruiting
Tartu, Estonia, 51003
Contact: Mare Saag, PhD    +372 7 319 855   
Contact: Rita Nommela, PhD    +372 7 319 860   
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
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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
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Mare Saag prof, University of Tartu Identifier: NCT01062633    
Other Study ID Numbers: N012/95
VARST 07264 2008-2011
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: December 2007
Keywords provided by University of Tartu:
dental caries
dietary supplements
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Vasodilator Agents
Gastrointestinal Agents