Clinical trial NCT03078179: Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Longum in Children Aged 3 to 5 Years of Villavicencio and Pasto
Official title: Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Longum in Children Aged 3 to 5 Years of Villavicencio and Pasto
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries, Dental
Keywords: Probiotic
Child
Care, dental
Lead sponsor: Cooperative University of Colombia
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2017-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this pilot study is to determine if the presence of bacteria with probiotic characteristics (Lactobacillus rhamnosus GG and Bifidobacterium longum) in a commercial milk, control some measures that indicate cariogenic processes.

Detailed description: Dental caries is a disease caused by a shift in pH balance, resulting in the formation of a biofilm composed mainly of cariogenic microflora. The interaction between this microflora and host factors conditions the deceleration or acceleration of the disease. Some biotechnology tools have been tried based on all this research, including probiotics, intended for a selective control of the etiological agents of caries and the maintenance of oral homeostasis.

Methodology: In this study, preschool children belonging to public preschool in Villavicencio and Pasto, Colombia will be invited to participate. After obtaining parent´s informed consent, the children will start commercial milk (nanPro3 Nestlé) intake without probiotic for 3 months. One week after, they will start commercial milk with probiotic during others 3 months. Clinical and microbiological testing of saliva at baseline, 3 m, and 6m will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and Established decay tooth (according to ICDAS) and quantification of Streptococci of the mutans group. Expected results: Statistically significant decrease in pH drop, demineralization in decay tooth and quantification of Streptococci of the mutans group.

Eligibility criteria: Inclusion Criteria:

* Pre-school children from age 3 to 5.
* Healthy children from a general health perspective, with early stage decay and established decay

Exclusion Criteria:

* Children with systemic disorders who need special care and / or who have intolerance to milk drinks or allergy to any of the components of the experimental and / or placebo beverage.
* Children who don't like milk.
* Children whit severe decay

Primary outcomes:
measure: Change in remineralization of tooth decay
timeFrame: 3 months
Secondary outcomes:
measure: Change of pH of saliva before and after a rinse with sugar.
timeFrame: 3 months
measure: Change of Dental Plaque Index
timeFrame: 3 months
measure: Change of concentration of group mutans streptococci in saliva
timeFrame: 3 months
Other outcomes:
Locations:
city: Villavicencio
country: Colombia
facility: Hogar Infantil 20 de Julio
state: Meta
city: Villavicencio
country: Colombia
facility: Hogar Infantil La Esperanza
state: Meta
city: Pasto
country: Colombia
facility: Cdi Nidos Nutrir
Study officials:
affiliation: Cooperative University of Colombia
name: María del Pilar Angarita, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahola AJ, Yli-Knuuttila H, Suomalainen T, Poussa T, Ahlstrom A, Meurman JH, Korpela R. Short-term consumption of probiotic-containing cheese and its effect on dental caries risk factors. Arch Oral Biol. 2002 Nov;47(11):799-804. doi: 10.1016/s0003-9969(02)00112-7.
citation: Aminabadi NA, Erfanparast L, Ebrahimi A, Oskouei SG. Effect of chlorhexidine pretreatment on the stability of salivary lactobacilli probiotic in six- to twelve-year-old children: a randomized controlled trial. Caries Res. 2011;45(2):148-54. doi: 10.1159/000325741. Epub 2011 Mar 31.
citation: Twetman L, Larsen U, Fiehn NE, Stecksen-Blicks C, Twetman S. Coaggregation between probiotic bacteria and caries-associated strains: an in vitro study. Acta Odontol Scand. 2009;67(5):284-8. doi: 10.1080/00016350902984237.
citation: Nase L, Hatakka K, Savilahti E, Saxelin M, Ponka A, Poussa T, Korpela R, Meurman JH. Effect of long-term consumption of a probiotic bacterium, Lactobacillus rhamnosus GG, in milk on dental caries and caries risk in children. Caries Res. 2001 Nov-Dec;35(6):412-20. doi: 10.1159/000047484.