NCT02398695|Completed
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Sponsor study identifier
Secondary identifiers
NIH
OTHER · Univeristy of Florida
observational
232
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 27, 2015
Actual (reported)Study Completion
August 27, 2015
Actual (reported)The fact that dental caries remains a major public health problem mandates that oral-health researchers explore new strategies for assessment of caries risk, as well as for caries prevention and management. Dental caries occurs when acids produced by bacterial glycolysis of dietary carbohydrates causes demineralization of the tooth enamel. A major focus of caries research has been on identifying and characterizing acid-generating bacteria and the mechanisms of acid resistance. The purpose of this study is to investigate over time the relationship between alkali production and caries.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 27, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 20, 2015
Actual (reported)March 25, 2015
Actual (reported)August 27, 2015
Actual (reported)August 27, 2015
Actual (reported)Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Changes from baseline to month 6
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Changes from baseline to month 6 to month 12
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Changes from baseline to month 6 to month 12 to month 18
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18 to month 24.
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6.
Changes from baseline to month 6
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.
Changes from baseline to month 6 to month 12
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.
Changes from baseline to month 6 to month 12 to month 18,
Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18 to month 24.
Changes from baseline to month 6 to month 12 to month 18 to month 24.
Participants who do not have caries (cavities) will have oral samples collected.
Participants who do have caries (cavities) will have oral samples collected.
Oral samples of saliva, dental plaque and DNA will be collected between the two groups.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population will consist of unrelated children aged between 2 and 5 years with different levels of caries experience.
Dental Clinical Research Unit, University of Florida
Gainesville, Florida, 32610, United States
Nascimento MM, Liu Y, Kalra R, Perry S, Adewumi A, Xu X, Primosch RE, Burne RA. Oral arginine metabolism may decrease the risk for dental caries in children. J Dent Res. 2013 Jul;92(7):604-8. doi: 10.1177/0022034513487907. Epub 2013 May 2.
Saliva and Plaque
Marcelle Nascimento, DDS, MS, PhD
University of Florida
232 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2015
First Posted
March 25, 2015
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
CAMBRA - PBRN Caries Management By Risk Assessment In A Practice-Based Research Network
Changes from baseline to month 6 to month 12 to month 18 to month 24
Contact the study team to confirm eligibility.
Primary Completion
August 27, 2015
Actual (reported)Study Completion
August 27, 2015
Actual (reported)Last Updated
November 13, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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