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Effect of Erythritol and Xylitol on Dental Caries Prevention in Children

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
University of Turku
Information provided by:
University of Tartu

Study Description
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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 Design
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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

Arms and Interventions
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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


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

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

Eligibility Criteria
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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
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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
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Publications:

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

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 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
prevention
dietary supplements

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Sorbitol
 Erythritol
Cathartics
Gastrointestinal Agents
Vasodilator Agents