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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 : July 30, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Dental Caries Other: Oral Samples

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
Actual Enrollment : 232 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)
Study Start Date : October 2012
Actual Primary Completion Date : August 27, 2015
Actual Study Completion Date : August 27, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Group/Cohort Intervention/treatment
Caries Free
Participants who do not have caries (cavities) will have oral samples collected.
Other: Oral Samples
Oral samples of saliva, dental plaque and DNA will be collected between the two groups.

Caries Active
Participants who do have caries (cavities) will have oral samples collected.
Other: Oral Samples
Oral samples of saliva, dental plaque and DNA will be collected between the two groups.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples With DNA
Saliva and Plaque


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398695


Locations
United States, Florida
Dental Clinical Research Unit, University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Marcelle Nascimento, DDS, MS, PhD University of Florida

Publications of Results:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02398695     History of Changes
Other Study ID Numbers: 272-2012 SubStudy-N
K23DE023579 ( U.S. NIH Grant/Contract )
IRB201600154 ( Other Identifier: Univeristy of Florida )
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Keywords provided by University of Florida:
Plaque
Saliva
Caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases