Microbial Testing for Caries Risk Assessment

NCT03389373 | Withdrawn DMC FDA Device

• 1 other identifier: 17-1535
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims 1\) Assess CG (Cariogenic) Saliva-Check Mutans® saliva testing for identification of high caries risk patients

Conditions

Dental Caries

Keywords

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Count of Strep Mutans bacterial

  Bacterial (MS) samples resulting in〖5x10〗\^5 colony-forming units per milliliter of saliva (CFU/mL) indicates a low caries risk. In contrast, \>〖5x10〗\^5 CFU/mL of MS in a saliva sample correlates to a moderate or high caries risk. This study is designed to use saliva sampling to determine a non-surgical adjunctive therapy to help lower cavity causing bacteria.

  4 weeks

Secondary Outcomes (1)

• Plaque Index

  4 weeks

Study Arms (1)

Child with full primary dentition

OTHER

All children who match inclusion criteria are eligible to have a saliva sample obtained which will act as a proxy for bacterial levels. High bacteria levels are correlated with a higher risk of developing cavities.

Device: GC Strep Mutans Saliva Sampling

Interventions

GC Strep Mutans Saliva Sampling DEVICE

Children who match inclusion criteria will have a saliva sample obtained which will act as a proxy for bacterial levels.

Child with full primary dentition

Eligibility Criteria

• Age: 24 Months - 96 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must be a patient of record at Children's Hospital Colorado Dental Center
• Child must fall between 24 and 96 months of age
• Child must present with full primary dentition

You may not qualify if:

• Patients with a complex medical history classified as being greater than ASA II
• Patients with recent dose of antibiotics within the previous two weeks or who present with a low caries risk set forth by the AAPD

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children'S Hospital Colorado Dental Center

Aurora, Colorado, 80045, United States

Location

Related Publications (9)

• Dye BA, Li X, Beltran-Aguilar ED. Selected oral health indicators in the United States, 2005-2008. NCHS Data Brief. 2012 May;(96):1-8.

  PMID: 23050519 RESULT

• Larson K, Cull WL, Racine AD, Olson LM. Trends in Access to Health Care Services for US Children: 2000-2014. Pediatrics. 2016 Dec;138(6):e20162176. doi: 10.1542/peds.2016-2176. Epub 2016 Nov 15.

  PMID: 27940710 RESULT

• Mills C, Patel P. Adopting caries risk assessment in all practice environments. Gen Dent. 2016 Jul-Aug;64(4):66-72.

  PMID: 27367637 RESULT

• Edelstein BL, Ureles SD, Smaldone A. Very High Salivary Streptococcus Mutans Predicts Caries Progression in Young Children. Pediatr Dent. 2016;38(4):325-30.

  PMID: 27557922 RESULT

• Li Y, Argimon S, Schon CN, Saraithong P, Caufield PW. Characterizing Diversity of Lactobacilli Associated with Severe Early Childhood Caries: A Study Protocol. Adv Microbiol. 2015 Jan 1;5(1):9-20. doi: 10.4236/aim.2015.51002.

  PMID: 26413427 RESULT

• Leone CW, Oppenheim FG. Physical and chemical aspects of saliva as indicators of risk for dental caries in humans. J Dent Educ. 2001 Oct;65(10):1054-62.

  PMID: 11699977 RESULT

• Thibodeau EA, O'Sullivan DM, Tinanoff N. Mutans streptococci and caries prevalence in preschool children. Community Dent Oral Epidemiol. 1993 Oct;21(5):288-91. doi: 10.1111/j.1600-0528.1993.tb00776.x.

  PMID: 8222603 RESULT

• Lee C, Tinanoff N, Minah G, Romberg E. Effect of Mutans streptococcal colonization on plaque formation and regrowth in young children--a brief commnunication. J Public Health Dent. 2008 Winter;68(1):57-60. doi: 10.1111/j.1752-7325.2007.00050.x.

  PMID: 18494159 RESULT

• Amaechi BT, Ramalingam K, Mensinkai PK, Chedjieu I. In situ remineralization of early caries by a new high-fluoride dentifrice. Gen Dent. 2012 Jul-Aug;60(4):e186-92.

  PMID: 22782050 RESULT

Related Links

• Guideline on Fluoride Therapy
• Guideline on Caries-risk Assessment and Management for Infants, Children, and Adolescence
• Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Camille V Gannam, DMD MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Provider and investigator will know if child has clinical caries or not at the time of saliva sample.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will have a saliva sample analyzed for amount of bacteria. Children who have higher bacteria counts are at higher risk of developing cavities.

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 3, 2018
• Study Start: February 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)