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

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02368028
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
131
1
6
21.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Oral Samples

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
131 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Oral Alkali Production and Caries Prevention in Children (Cross-sectional Component)
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Arginolytic activity in oral samples [Day 1]

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

Secondary Outcome Measures

  1. Type of oral bacteria [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 Outcome Measures

  1. Oral health [Day 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02368028
Other Study ID Numbers:
  • 272-2012
  • K23DE023579
First Posted:
Feb 20, 2015
Last Update Posted:
Sep 15, 2015
Last Verified:
Sep 1, 2015
Keywords provided by University of Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2015