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NCT Number: NCT02398695

Oral Alkali Production and Caries Prevention in Children (Longitudinal)

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.

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Key information

Conditions

Dental Caries Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Clinical Research Unit, University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Samples

Other

Oral samples of saliva, dental plaque and DNA will be collected between the two groups.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Institutes of Health (NIH)

Registry information

Official study title

Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2015
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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