Xylitol in milk to prevent tooth decay in children

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34705772

Enrollment

160

Registered

2014-03-10

Start date

2014-03-10

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth decay (dental caries) Oral Health

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Streptococcus mutans levels change from baseline to end of study	—

Countries

Peru

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026