Microbial Testing for Caries Risk Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03389373
Recruitment Status : Withdrawn (Saliva testing was not sensitive enough to correctly identify high risk patients)
First Posted : January 3, 2018
Last Update Posted : July 16, 2018
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Specific Aims

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

Condition or disease Intervention/treatment Phase
Dental Caries Device: GC Strep Mutans Saliva Sampling Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Children will have a saliva sample analyzed for amount of bacteria. Children who have higher bacteria counts are at higher risk of developing cavities.
Masking: None (Open Label)
Masking Description: Provider and investigator will know if child has clinical caries or not at the time of saliva sample.
Primary Purpose: Diagnostic
Official Title: Microbial Testing for Caries Risk Assessment
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Child with full primary dentition
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
Children who match inclusion criteria will have a saliva sample obtained which will act as a proxy for bacterial levels.

Primary Outcome Measures :
  1. Count of Strep Mutans bacterial [ Time Frame: 4 weeks ]
    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.

Secondary Outcome Measures :
  1. Plaque Index [ Time Frame: 4 weeks ]
    An index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin. A score of 0 to 3 (0=no plaque, 1=minimal plaque, 2 = moderate plaque, 3= extensive plaque is assigned to each of 5 division on the tooth). The score is then divided by 5. The patient's resultant plaque rating is considered excellent if the score is 0, Good if it is between 0.1-1.7, Fair if it is between 1.8-3.4 and Poor if it is between 3.5-5. The hope is to see a reduction of plaque score in study participants at the follow-up visit 4 weeks later.

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Ages Eligible for Study:   24 Months to 96 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03389373

United States, Colorado
Children'S Hospital Colorado Dental Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Camille V Gannam, DMD MS University of Colorado, Denver

Additional Information:
Publications of Results:

Responsible Party: University of Colorado, Denver Identifier: NCT03389373     History of Changes
Other Study ID Numbers: 17-1535
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a small resident research project comparing the effect of Prevident5000 plus versus over the counter toothpaste on cariogenic bacteria counts as well as the effect of frequent hygiene reminders on oral hygiene (plaque score).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Colorado, Denver:
Dental Caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases