Clinical trial NCT02398695: Oral Alkali Production and Caries Prevention in Children (Longitudinal)
Official title: Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: Plaque
Saliva
Caries
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2015-03-25
Enrollment: 232
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6.
timeFrame: Changes from baseline to month 6
measure: 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.
timeFrame: Changes from baseline to month 6 to month 12
measure: 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.
timeFrame: Changes from baseline to month 6 to month 12 to month 18
measure: 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.
timeFrame: Changes from baseline to month 6 to month 12 to month 18 to month 24
Secondary outcomes:
measure: Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6.
timeFrame: Changes from baseline to month 6
measure: Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.
timeFrame: Changes from baseline to month 6 to month 12
measure: Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.
timeFrame: Changes from baseline to month 6 to month 12 to month 18,
measure: 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.
timeFrame: Changes from baseline to month 6 to month 12 to month 18 to month 24.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Dental Clinical Research Unit, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Marcelle Nascimento, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.