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

  Hide Detailed Description

Detailed Description:

Rationale: Several polyols (xylitol, sorbitol, erythritol) have been shown to act as excellent sugar substitutes, especially for in-between meals food products. Most commonly they are used in chewing gums, but the recent field trials also show a clear effectiveness of xylitol lozenges. Although sorbitol is metabolized at a slower rate than sucrose and not at all by most microorganisms, it can be fermented at a slow rate by all of the mutans streptococci including S. mutans while xylitol and erythritol are considered to be non-acidogenic. It has been demonstrated in some studies that xylitol reduces to a greater extent caries rate than sorbitol, however, the scientific committee on medicinal products is of the opinion that no clear data support the concept that xylitol possesses specific effects in vivo which validate a superiority claim over other polyols.

Objective: It is believed that the benefits of sugar-free gums may be twofold; 1) decreased lactic acid production and increased salivary flow potentially leading to an increased buffering of acids in plaque and 2) increased supersaturation of saliva with the mineral ions as well as enhanced clearance of sugars from the mouth. Thus sugar substitution and salivary stimulation could, it has been argued, be equally responsible for the noncariogenicity of sugar-free chewing gum. By comparing long term effects of several polyols, on possible remineralization effect on incipient caries lesions and on preventing the new caries lesions in comparison with sorbitol,the study will help demonstrate the superiority of erythritol and eventually xylitol over sorbitol and will help demonstrate the role of sugar substitutes, beyond saliva stimulation-mediated oral benefits on dental caries prevention.Sorbitol lozenges are used as a positive control. The saliva and plaque sample analyses would reveal the possible mechanisms of the expected caries preventive effects.

Study design: This is a double-blind, parallel, randomized, controlled study in primary school children around Tartu city. The allocation of the children into three groups will be based on classrooms for the practical reasons. The classrooms will be randomly allocated into the intervention and control groups. The study will last three years. During the first 2 years, the two intervention groups will consume either xylitol or erythritol-containing lozenges and the control group will be provided with sorbitol-containing tablets Then, there will be two options, depending on the effects on caries prevention after 2 years feeding with the polyols and depending on the SD of the caries incidence,. If the SD >2, the groups will not be spilt up as the power of the study would not be high enough to see any statistical effect. In this case, during the third experimental year, groups will stop eating polyol-containing lozenges and tablets to assess the lasting preventive effects of the polyol. If the SD<2 , the groups will be spilt up into two sub-groups, where one sub-group will stop eating polyols-containing lozenges to assess the lasting effect of polyol on caries prevention and the other sub-group will continue consuming the polyol-containing lozenges to assess the long-term effect of polyol intake on caries prevention.

Study population: The classrooms of 1st and 2nd primary schoolchildren (n=450) will be randomly allocated into two intervention groups (erythritol and xylitol) and into one positive control group (sorbitol. The list of the 1st and 2nd graders classrooms will be used as a sample frame. The allocation of the classrooms will be based on the random numbers generated by a computer.

Intervention: The test products will be distributed to the pupils in all (erythritol, xylitol, and sorbitol) groups three times a day during the school days (about 200/year) by the teachers.

Main study parameters/endpoints: All children will be clinically examined at the beginning of the trial, one -, two - and three years after the baseline examinations. All the surfaces of the mixed dentition (primary and permanent teeth) will be examined. The mean annual incipient and dentinal caries increment will be calculated. The teeth (FT) and surfaces (FS) restored or extracted because of caries during the study period will be calculated and included in the caries experience indices (dmft/DMFT). The plaque and saliva samples will be collected in each examination.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There will be clinical examinations and plaque sample collection of the study subjects four times in this study. Each examination will take about 15 min. No risks for the pupils can be expected from these examinations. The children will be given a toothbrush and toothpaste every 6 months. After the study examinations, pupils will be driven to a museum by bus.

  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 31, 2014