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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368028
• Other study ID #: 272-2012
• Secondary ID: K23DE023579
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: September 14, 2015
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Oral Samples
Oral samples of saliva, dental plaque and DNA will be collected between the two groups.

Locations

Country	Name	City	State
United States	Dental Clinical Research Unit, University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oral health	Oral exam will be performed to determine the oral health or disease status of the participants.	Day 1	No
Primary	Arginolytic activity in oral samples	Oral samples, saliva and dental plaque, will be collected and their arginolytic activity wil be compared between the two groups.	Day 1	No
Secondary	Type of oral bacteria	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.	Day 1	No