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

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 |

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 |
- caries reduction [ Time Frame: 3 years ]
- Depression of oral microorganisms [ Time Frame: 3 years ]

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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

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
Contact: Mare Saag, PhD | +372 7319855 | mare.saag@ut.ee | |
Contact: Rita Nommela, PhD | +372 7319860 | rita.nommela@ut.ee |
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 |
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mare Saag prof, University of Tartu |
ClinicalTrials.gov 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 |
dental caries prevention dietary supplements |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Erythritol |
Sorbitol Vasodilator Agents Cathartics Gastrointestinal Agents |