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Oral Alkali Production and Caries Prevention in Children (Longitudinal)

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ClinicalTrials.gov Identifier: NCT02398695
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : November 12, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date March 20, 2015
First Posted Date March 25, 2015
Last Update Posted Date November 12, 2018
Study Start Date October 2012
Actual Primary Completion Date August 27, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2015)
  • Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6. [ Time Frame: Changes 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.
  • 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. [ Time Frame: Changes 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.
  • 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. [ Time Frame: Changes 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.
  • 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. [ Time Frame: Changes 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02398695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 20, 2015)
  • Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6. [ Time Frame: Changes from baseline to month 6 ]
    Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
  • Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12. [ Time Frame: Changes from baseline to month 6 to month 12 ]
    Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
  • Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18. [ Time Frame: Changes from baseline to month 6 to month 12 to month 18, ]
    Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
  • 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. [ Time Frame: Changes from baseline to month 6 to month 12 to month 18 to month 24. ]
    Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Alkali Production and Caries Prevention in Children (Longitudinal)
Official Title Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)
Brief Summary 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.
Detailed Description This study will require a total of 6 study visits over a 2 to 3 year period. The first study visit will last about one hour. At this study visit, parent-administered questionnaires will be used to collect information on the following: (a) the participant's demographic background (age, gender, and race), (b) socio-economic status (parents' income and housing condition), (c) participant's oral health practice (feeding histories, diet habits, oral hygiene measures, and dental attendance), and (d) systemic diseases. During the study visit, the participant's complete medical and dental history will be obtained and reviewed, and a dental exam will be performed in order to determine participants' caries status, and intraoral pictures may be taken of participants' teeth. At this visit and remaining visits participants will not be allowed to brush or clean teeth using any type of oral hygiene procedures for 8 hours prior to the visit. Saliva and plaque (the solf white-yellowish material on the tooth surface) will be collected at each visit. The Investigator will use a small probe to measure the pH of the dental plaque that builds up on the teeth. The participant will be asked to dip one finger into a glass containing a buffer solution and the probe will be placed on the teeth from which plaque will be taken. Plaque samples will be collected by gently scrapping the tooth using a sterile instrument. If the participant does not have enough plaque samples, they will be asked to return on the following day.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva and Plaque
Sampling Method Probability Sample
Study Population The study population will consist of unrelated children aged between 2 and 5 years with different levels of caries experience.
Condition Dental Caries
Intervention Other: Oral Samples
Oral samples of saliva, dental plaque and DNA will be collected between the two groups.
Study Groups/Cohorts
  • Caries Free
    Participants who do not have caries (cavities) will have oral samples collected.
    Intervention: Other: Oral Samples
  • Caries Active
    Participants who do have caries (cavities) will have oral samples collected.
    Intervention: Other: Oral Samples
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2018)
232
Original Estimated Enrollment
 (submitted: March 20, 2015)
310
Actual Study Completion Date August 27, 2015
Actual Primary Completion Date August 27, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 2 to 7 years

Exclusion Criteria:

  • Treated with antibiotics within the past 3 months
  • taking any medication at the time of the study
  • uses orthodontic appliance, and
  • has performed oral hygiene procedures in the past 8 hour prior to the collection appointment.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 7 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02398695
Other Study ID Numbers 272-2012 SubStudy-N
K23DE023579 ( U.S. NIH Grant/Contract )
IRB201600154 ( Other Identifier: Univeristy of Florida )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Marcelle Nascimento, DDS, MS, PhD University of Florida
PRS Account University of Florida
Verification Date November 2018