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

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ClinicalTrials.gov Identifier: NCT02368028
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : September 15, 2015
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 February 13, 2015
First Posted Date February 20, 2015
Last Update Posted Date September 15, 2015
Study Start Date March 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02368028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 13, 2015)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 13, 2015)
Oral health [ Time Frame: Day 1 ]
Oral exam will be performed to determine the oral health or disease status of the participants.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Oral Alkali Production and Caries Prevention in Children (Cross-sectional Component)
Official Title Oral Alkali Production and Caries Prevention in Children (Cross-sectional 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 the type of bacteria that grows in the mouth and on teeth.
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 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 Dental 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: September 14, 2015)
131
Original Estimated Enrollment
 (submitted: February 13, 2015)
120
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 5 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 NCT02368028
Other Study ID Numbers 272-2012
K23DE023579 ( U.S. NIH Grant/Contract )
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, PhD University of Florida
PRS Account University of Florida
Verification Date September 2015