Oral Alkali Production and Caries Prevention in Children (Longitudinal)

Dental Caries Clinical Trial

Official title:

Oral Alkali Production and Caries Prevention in Children (Longitudinal Component)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398695
• Other study ID #: 272-2012 SubStudy-N
• Secondary ID: K23DE023579IRB20
• Status: Completed
• Start date: October 2012
• Est. completion date: August 27, 2015

Study information

• Verified date: November 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• 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 over time the relationship between alkali production and caries.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: August 27, 2015
• Est. primary completion date: August 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

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
Primary	Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects change from baseline to month 6.	Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.	Changes from baseline to month 6
Primary	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.	Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.	Changes from baseline to month 6 to month 12
Primary	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.	Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.	Changes from baseline to month 6 to month 12 to month 18
Primary	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.	Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.	Changes from baseline to month 6 to month 12 to month 18 to month 24
Secondary	Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6.	Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.	Changes from baseline to month 6
Secondary	Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.	Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.	Changes from baseline to month 6 to month 12
Secondary	Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.	Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.	Changes from baseline to month 6 to month 12 to month 18,
Secondary	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.	Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.	Changes from baseline to month 6 to month 12 to month 18 to month 24.