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-schoolers 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
ohnmar@u.washington.edu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
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
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dental caries
Intervention
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
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
01/09/2010
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
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
Patient
Age group
Child
Gender
Both
Target number of participants
200 participants
Participant exclusion criteria
Allergy or sensitivity to fluoride toothpaste
Recruitment start date
01/09/2010
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Marshall Islands
Trial participating centre
Republic of the Marshall Islands
Majuro
96960
Marshall Islands
Funders
Funder type
Government
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
Location
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
Results - basic reporting
Publication summary