Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-31 @ 4:20 AM
Study NCT ID:
NCT02398695
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Alkali Production and Caries Prevention in Children (Longitudinal)
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23DE023579 | NIH | None | https://reporter.nih.gov/quic… | View |
| IRB201600154 | OTHER | Univeristy of Florida | View |