Microbial Testing for Caries Risk Assessment
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|ClinicalTrials.gov 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Recruitment Status : Withdrawn (Saliva testing was not sensitive enough to correctly identify high risk patients)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
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.|
|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|
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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03389373
|United States, Colorado|
|Children'S Hospital Colorado Dental Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Camille V Gannam, DMD MS||University of Colorado, Denver|