An interventional study of Commercial Dairy Cow Milk and Commercial Cow Milk with Probiotic in Caries, Dental, sponsored by Cooperative University of Colombia. Completed at 3 sites in Colombia. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-23.
Sponsored by Cooperative University of Colombia · Not applicable, Interventional, and Other
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.
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.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
Probiotic enriched cow milk: 200 ml of commercial nutritive milk fortified with probiotic Lactobacillus rhamnosus and Bifidobacterium longum once a day.
Dietary Supplement: Commercial Cow Milk with Probiotic
200 ml of commercial nutritive milk without probiotic, once a day,
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.
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.
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)
Time frame: 3 months
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).
Time frame: 3 months
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).
Time frame: 3 months
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
Time frame: 3 months
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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