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Completed

NCT Number: NCT02368028

Oral Alkali Production and Caries Prevention in Children (Cross-sectional Component)

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 the type of bacteria that grows in the mouth and on teeth.

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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–5 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 only one visit. The study visit will last about one hour. At the 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.

Participants will not be allowed to brush or clean teeth using any type of oral hygiene procedures for 8 hours prior to sample collection. Saliva and plaque (The solf white-yellowish material on the tooth surface) will be collected. 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.

Dental plaque will be collected from the participants between the ages of 2 and 5 with at least two teeth and who allow the dental examination and the sample collection procedures to be done safely. 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. Saliva will be collected by using cotton swabs or by asking the participant to spit into a sterile plastic container.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 2 to 5 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. Arginolytic activity in oral samples

    Time frame: Day 1

    Oral samples, saliva and dental plaque, will be collected and their arginolytic activity wil be compared between the two groups.

Secondary outcomes

  1. Type of oral bacteria

    Time frame: Day 1

    DNA and RNA samples will be extracted from saliva and dental plaque and the type of oral bacteria and their metabolism present on theses samples will be compared between the two groups.

Other outcomes

  1. Oral health

    Time frame: Day 1

    Oral exam will be performed to determine the oral health or disease status of the participants.

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2015
Registry last updated
Sep 15, 2015

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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