Condition category
Oral Health
Date applied
28/02/2014
Date assigned
10/03/2014
Last edited
10/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Since 1983, Peru's Glass of Milk Program has targeted schools in low-income communities and provides every low-income child with a daily glass of milk. While the program has good public health intentions, milk for young children in Peru is sweetened with table sugar (sucrose) and honey, which exposes children already at high risk for dental disease to additional sugar. Xylitol is a safe and acceptable sugar substitute that reduces Streptococcus mutans, the main bacteria linked to dental caries. However, studies to date have not tested whether xylitol in milk is an effective community-based strategy to prevent caries (tooth decay) in vulnerable children. This study will compare xylitol milk with sorbitol milk and sucrose milk.

Who can participate?
Children in kindergarten through third grade studying in the participating school can take part in the study.

What does the study involve?
The children will be randomly allocated to receive either xylitol in their milk once or twice per day, sorbitol in their milk once or twice per day, or sucrose in their milk once per day. The increase in dental caries (in both the primary molars and permanent first molars) and the level of the bacteria S. mutans will be measured after 10 months.

What are the possible benefits and risks of participating?
A potential benefit is the fact that all children will receive a dental screening. Any children with dental disease will be sent home with a letter that summarizes the child's oral health status, any recommendations for treatment, and a referral to a local dental clinic (if needed). Another potential benefit is reduced tooth decay rates for children in the experimental groups (xylitol or sorbitol). In terms of risks, there is a very small chance that a child could develop minor stomach discomfort from taking in large doses of xylitol. The child might also find the dental examination to be uncomfortable.

Where is the study run from?
This study will be conducted at I.E. San Jose de Cottolengo School, Arequipa, Peru.

When is study starting and how long is it expected to run for?
The study will start in March 2014 and will run until December 2014. We will recruit participants for one week (10th March-14th March).

Who is funding the study?
International Association of Dental Research (USA).

Who is the main contact?
Dr Donald Chi
dchi@uw.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Donald Chi

ORCID ID

Contact details

1959 NE Pacific Street
B509f
Seattle
98195
United States of America
+1 (0)206 616 4332
dchi@uw.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Peru's Glass of Milk Program (Programa Social Vaso de Leche): Using xylitol in milk in a community-based nutrition program to prevent dental caries in children

Acronym

Study hypothesis

Our main study hypothesis is that adding xylitol to milk will be more efficacious at preventing tooth decay in children than sorbitol or sucrose. Our secondary hypothesis is that adding xylitol to milk will be more efficacious at reducing intraoral levels of tooth decay-causing bacteria than sorbitol or sucrose.

Ethics approval

Ethics Committee at the Universidad Católica de Santa Maria, 02/02/2014
University of Washington IRB, 12/03/2014

Study design

Prospective randomised five-arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

Tooth decay (dental caries)

Intervention

1. Xylitol in milk (twice per day)
2. Xylitol in milk (once per day)
3. Sorbitol in milk (twice a day)
4. Sorbitol in milk (once per day)
5. Sucrose in milk (once per day)

The total duration of the intervention is about 9 months (March 2014 to December 2014). There is one baseline exam (March) and one end-of-study exam (December).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Caries increment (in primary molars and permanent first molars) from baseline to end of study

Both outcomes will be measured twice: at baseline (in March 2014 before children are randomized into one of the five milk arms) and at end-of study (in December 2014 when the intervention will end). Dental caries will be measured using World Health Organization caries criteria, which is approved for use by the U.S. National Institute of Dental and Craniofacial Research (NIDCR), the main federal funding agency in the U.S. for dental research. Intraoral bacterial levels will be enumerated twice (at baseline in March 2014 and when the intervention ends in December 2014) using standard microbiological mutan streptococci enumeration techniques.

Secondary outcome measures

Streptococcus mutans levels change from baseline to end of study

Overall trial start date

07/03/2014

Overall trial end date

20/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Grades K to 3 (ages 4 to 10 years) at baseline
2. Attend the I.E. San Jose de Cottolengo School in the district of Melgar, Arequipa, Peru

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

160

Participant exclusion criteria

1. If the child has been taking antibiotics during the last four weeks from baseline
2. No caregiver consent or child assent
3. Allergy to milk or lactose intolerant
4. Unable to cooperate for a dental exam

Recruitment start date

10/03/2014

Recruitment end date

14/03/2014

Locations

Countries of recruitment

Peru

Trial participating centre

1959 NE Pacific Street, B509f
Seattle
98195
United States of America

Sponsor information

Organisation

International Association of Dental Research (USA)

Sponsor details

1619 Duke Street
Alexandria
22314
United States of America
+1 (0)703 299 8094
sherren@iadr.org

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

International Association of Dental Research (USA)

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