Condition category
Oral Health
Date applied
18/11/2011
Date assigned
06/01/2012
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
ohnmar@u.washington.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ohnmar Tut

ORCID ID

Contact details

Republic of the Marshall Islands
Ministry of Health
Post Office Box 16
Majuro
96960
Marshall Islands

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

Sponsor information

Organisation

Republic of the Marshall Islands (Marshall Islands)

Sponsor details

c/o Dr Ohnmar Tut
Ministry of Health
Post Office Box 16
Majuro
96960
Marshall Islands

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes