Oral Alkali Production and Caries Prevention in Children (Longitudinal)

NCT02398695 | Completed

• 3 other identifiers: 272-2012 SubStudy-NK23DE023579IRB201600154
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Plaque; Saliva; Caries

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6.

  Changes from baseline to month 6

• Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12.

  Changes from baseline to month 6 to month 12

• Bacteria collected from oral samples of healthy and caries-active subjects change from baseline to month 6 to month 12 to month 18.

  Changes from baseline to month 6 to month 12 to month 18,

• 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.

  Changes from baseline to month 6 to month 12 to month 18 to month 24.

Study Arms (2)

Caries Free

Participants who do not have caries (cavities) will have oral samples collected.

Other: Oral Samples

Caries Active

Participants who do have caries (cavities) will have oral samples collected.

Other: Oral Samples

Interventions

Oral Samples OTHER

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

Caries Active; Caries Free

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age 2 to 7 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Dental Clinical Research Unit, University of Florida

Gainesville, Florida, 32610, United States

Location

Related 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.

  PMID: 23640952 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and Plaque

MeSH Terms

Conditions

Dental Caries; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcelle Nascimento, DDS, MS, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: October 1, 2012
• Primary Completion: August 27, 2015
• Study Completion: August 27, 2015
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

US (1)