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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03078179
Other study ID # ID 1532
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2017
Est. completion date May 5, 2018

Study information

Verified date June 2018
Source Cooperative University of Colombia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 5, 2018
Est. primary completion date August 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Commercial Dairy Cow Milk
After obtaining parent´s informed consent and the baseline examination, from 3 to 5 years old, will start commercial dairy cow milk intake without probiotic (placebo) for 3 months. Clinical and microbiological testing of saliva at baseline and at the end will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and quantification of Streptococci of the mutans group.
Commercial Cow Milk with Probiotic
The children will initiate the milk intake with probiotic one week after having ingested the milk without probiotics. They will drink the milk with probiotic for 3 months. Clinical and microbiological testing of saliva will be performed. Clinical and microbiological testing of saliva at baseline and at the end will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and quantification of Streptococci of the mutans group.

Locations

Country Name City State
Colombia Cdi Nidos Nutrir Pasto
Colombia Hogar Infantil 20 de Julio Villavicencio Meta
Colombia Hogar Infantil La Esperanza Villavicencio Meta

Sponsors (2)

Lead Sponsor Collaborator
Cooperative University of Colombia Colgate Palmolive

Country where clinical trial is conducted

Colombia, 

References & Publications (4)

Ahola AJ, Yli-Knuuttila H, Suomalainen T, Poussa T, Ahlström 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. — View 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. — View Citation

Näse L, Hatakka K, Savilahti E, Saxelin M, Pönkä 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) — View Citation

Twetman L, Larsen U, Fiehn NE, Stecksén-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in remineralization of tooth decay DIAGNOdent peak reading in three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic (after 3 months) 3 months
Secondary Change of pH of saliva before and after a rinse with sugar. Saliva pH test in three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic (after 3 months). 3 months
Secondary Change of Dental Plaque Index Silness-Löe plaque index n three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic (after 3 months). 3 months
Secondary Change of concentration of group mutans streptococci in saliva Co(after 3 months).lony Forming Units (CFUs) determination in three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic 3 months
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