Condition category
Oral Health
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Dental caries (tooth decay) is the most common disease among pre-schoolers. Low-income pre-schoolers are more likely to be at risk for tooth decay. Current public health strategies have failed to significantly control tooth decay in this age group. This is an important problem to address because untreated tooth decay leads to pain, infection, which can lead to poor academic outcomes, systemic health problems, cellulitis, and in rare cases, death.
Currently, fluoride toothpaste is used to prevent tooth decay in pre-schoolers. Studies suggest that xylitol, a naturally-occurring sweetener, also helps to prevent tooth decay. Based on the idea that adding xylitol to fluoride toothpaste leads to a more effective product, toothpaste manufacturers have developed a xylitol+fluoride toothpaste. However, until now, no studies have been conducted that compare fluoride toothpaste to xylitol+fluoride toothpaste as a way to prevent tooth decay in pre-schoolers. The Head Start Program is a national program targeted at low-income pre-schoolers ages 3-5 years. The aim of the program is to prepare vulnerable pre-schoolers for kindergarten by ensuring good overall health. Many Head Start Programme classrooms include a tooth brushing program that is overseen by the classroom teacher. Teachers are trained to ensure the pre-schoolers follow the correct tooth brushing method. Currently, all Head Start classrooms that have a tooth brushing program use fluoride toothpaste.

Who can participate?
Pre-schoolers are healthy and that consent is received for participation by the pre-schooler’s caregiver.

What does the study involve?
This study will introduce xylitol-fluoride toothpaste to two Head Start classrooms and fluoride-toothpaste to two other Head Start classrooms. Our aim is to compare tooth decay rates for pre-schoolers in the two groups, from the start of the study to 9 months. We will also collect plaque and saliva samples at 9 months to see if the two groups differ in the levels of Streptococcus mutans, the bacteria which is responsible for plaque and tooth decay.

What are the possible benefits and risks of participating?
Pre-schoolers participating may be less likely to experience tooth decay. All tooth brushing activities were directly supervised by multiple classroom teachers, so the risks to the pre-schoolers were minimal.

Where is the study run from?
From four Head Start Programme classrooms in Majuro in the Republic of the Marshall Islands (50 pre-schoolers per classroom).

When is the study starting and how long is it expected to run for?
The study took place during the 2010/2011 school year.

Who is funding the study?
United States Health Resources and Services Administration - Targeted Oral Health Services Systems.

Who is the main contact?
Dr Ohnmar Tut

Trial website

Contact information



Primary contact

Dr Ohnmar Tut


Contact details

Republic of the Marshall Islands
Ministry of Health
Post Office Box 16
Marshall Islands

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A clinical trial comparing fluoride toothpaste and xylitol+fluoride toothpaste in reducing dental caries among pre-schoolers at increased risk for tooth decay: a randomised prospective trial


Study hypothesis

Xylitol+fluoride toothpaste is more effective than fluoride toothpaste at slowing the rates of tooth decay progression in pre-schoolers

Ethics approval

Not provided at time of registration

Study design

Single-center double-blinded classroom randomized prospective clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Dental caries


Arm 1: supervised in-class toothbrushing once/day with xylitol+1400ppm fluoride toothpaste
Arm 2: supervised in-class toothbrushing once/day with 1400ppm fluoride toothpaste

Intervention type



Not Applicable

Drug names

Primary outcome measure

Total increase in the number of primary tooth surfaces with untreated dental caries from baseline to end of school year

Secondary outcome measures

Levels of intraoral plaque and salivary mutans streptococci (at end of school year)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Enrolled in one of four pre-schools in Majuro, Marshall Islands
2. Under age 5
3. Parent consent to participate in the trial

Participant type


Age group




Target number of participants

200 participants

Participant exclusion criteria

Allergy or sensitivity to fluoride toothpaste

Recruitment start date


Recruitment end date



Countries of recruitment

Marshall Islands

Trial participating centre

Republic of the Marshall Islands
Marshall Islands

Sponsor information


Republic of the Marshall Islands (Marshall Islands)

Sponsor details

c/o Dr Ohnmar Tut
Ministry of Health
Post Office Box 16
Marshall Islands

Sponsor type




Funder type


Funder name

United States Health Resources and Services Administration (HRSA) (USA) - Targeted Oral Health Services Systems TOHSS Grant ref: H47MC08647

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes