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Effect of Erythritol and Xylitol on Dental Caries Prevention in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of Tartu.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Turku
Information provided by:
University of Tartu
ClinicalTrials.gov Identifier:
NCT01062633
First received: January 29, 2008
Last updated: February 3, 2010
Last verified: December 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Erythritol and Xylitol on Dental Caries Prevention in Children

Resource links provided by NLM:


Further study details as provided by University of Tartu:

Primary Outcome Measures:
  • caries reduction [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression of oral microorganisms [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: January 29, 2008
Last Updated: February 3, 2010
Health Authority: Estonia: The State Agency of Medicine

Keywords provided by University of Tartu:
dental caries
prevention
dietary supplements

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Erythritol
Sorbitol
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 24, 2014