Microbial Testing for Caries Risk Assessment
Primary Purpose
Dental Caries
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GC Strep Mutans Saliva Sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Dental Caries focused on measuring Dental Caries
Eligibility Criteria
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
Sites / Locations
- Children'S Hospital Colorado Dental Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Child with full primary dentition
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Plaque Index
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.
Full Information
NCT ID
NCT03389373
First Posted
December 22, 2017
Last Updated
July 12, 2018
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03389373
Brief Title
Microbial Testing for Caries Risk Assessment
Official Title
Microbial Testing for Caries Risk Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Saliva testing was not sensitive enough to correctly identify high risk patients
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Specific Aims
1) Assess CG (Cariogenic) Saliva-Check Mutans® saliva testing for identification of high caries risk patients
Detailed Description
Hypotheses and Specific Aims
Hypotheses CG Saliva-Check Mutans will test positive in children with clinical caries.
Specific Aims
Assess CG Saliva-Check Mutans saliva testing for identification of high caries risk patients
Background and Significance
Early Childhood Caries
Suboptimal oral health is an existing and growing concern for the pediatric patient, with dental decay considered the most common chronic disease of childhood in the United States. About 1 in 5 children (20%) aged 5 to 11 years old have at least one untreated decayed tooth, with childhood caries being 4 times more common than early childhood obesity, 5 times more common than asthma, and 20 times more common than diabetes. Early childhood caries (ECC) is diagnosed when one or more primary teeth are affected by the caries process before six years of age, and severe early childhood caries (S-ECC) is defined as any smooth-surface caries in a child under the age of three. ECC is a multifactorial process and is not exclusively associated with poor feeding habits such as ad libitum bottle or breast-feeding. Factors include susceptible tooth surfaces, frequent consumption of a cariogenic diet, and an elevated colonization of cariogenic bacteria. Mutans Streptococci (MS) are pathognomonic for ECC and S-ECC in all age groups. The rise of ECC and S-ECC has increased the number of children needing dental treatment at an early age, often requiring treatment in advanced care settings such as under sedation, general anesthesia, or the emergency department. Over 51 million school hours are lost each year due to dental problems or urgent dental needs. Furthermore, 44 % of children in the U.S. will suffer from pediatric dental disease before kindergarten and approximately 22% of people across all age groups have existing untreated dental decay. As health care providers, it is imperative for both dentists and pediatricians to promote optimal oral health through the utilization of prevention strategies, such as the caries risk assessment.
Caries Risk Assessment (CAMBRA)
The multiple factors that contribute to dental caries development should be evaluated to determine an individual patient's risk status. An evidence-based model termed Caries Management Risk Assessment (CAMBRA) was developed to provide dentists with a protocol for caries diagnosis, prevention and treatment. CAMBRA helps identify children at risk of caries development and provides age-specific recommendations for caries prevention across all demographics. The goal of the assessment is that by identifying a patient at high risk of caries development, the dental provider can make patient specific recommendations in attempt to lower risk and mitigate disease progression. The risk assessment for all patients determines biological, protective, and clinical factors that may contribute to the caries disease process. Examples of high risk factors for pediatric patients include frequent between meal sugar-containing foods and sugar sweetened beverages (SSB), nighttime bottle feeding, previous caries experience, and elevated MS levels. Protective factors against caries progression include optimal oral hygiene, topical fluoride, and sugar substitutes.
Concepts of a Healthy Mouth
A healthy mouth has a symbiotic environment of cariogenic and non-cariogenic bacteria and is characterized as being free of and at low risk for developing disease. A low plaque score (or low plaque growth) has a strong correlation with a healthier mouth for both dental and periodontal health. When the symbiotic relationship becomes unbalanced, the resulting acidic environment leads to demineralization of tooth structure. High levels of cariogenic bacteria such as Mutans Streptococci (MS) and Lactobacilli acidophilus (LB) lower environmental pH levels, which selects for progressive dissolution of mineral into saliva and causes an increased risk of caries development. Saliva is an important intrinsic host factor protecting against caries formation, as it provides a reservoir of calcium, phosphate and fluoride to remineralize affected enamel and acts as a buffer to reestablish a healthy oral pH. By educating parents of the pediatric patient about concepts of a healthy mouth and demonstrating good oral hygiene practices, a child can be at lower risk for dental decay.
Etiology of Caries
Dental caries is a multifactorial disease process that is driven primarily by a diet high in fermentable carbohydrates and simple sugars, cariogenic bacteria, and suboptimal oral hygiene. The prevailing microorganisms that contribute to the development of dental caries are MS and LB, which metabolize fermentable carbohydrates to produce acid (acidogenic) and thrive in low pH environments (aciduric). Frequent consumption of fermentable carbohydrates and SSBs leads to maintained levels of low salivary pH, resulting in the dissolution of calcium and phosphate from enamel surfaces over time. This demineralization of tooth structure presents initially as a white spot lesion, which can be reversed or remineralized by decreasing exposure to fermentable carbohydrates and practicing optimal oral hygiene. However, if the local oral environment is not improved to promote remineralization at these affected sites, mineral loss will continue until a physical breakdown or cavitation of the enamel's crystal lattice structure occurs, requiring surgical intervention to restore.
Prevention Measures and Adjective Therapies (Prevident5000)
Fluoride applications represent a non-surgical approach to enamel remineralization. High concentrations of fluoride, such as those found in toothpastes and varnishes, creates an altered layer of calcium (fluorapatite) on the tooth surface. Therefore, fluoride aides to increase the pH for acid resistance and decrease the adhesion of bacteria to smooth surfaces by directly affecting the metabolism activity of cariogenic bacteria. High fluoride containing toothpastes such as PreviDent5000 Plus (1.1 % NaF; 5,000ppm F) has been shown to be effective at increasing enamel remineralization and reducing dental caries in both the primary and permanent dentition. When used as an at home regimen, PreviDent5000 decreased lesion depths up to 24%, supporting the finding that dentifrices with 5,000ppm fluoride are more effective at remineralizing carious lesions compared to standard over the counter dentifrices containing 1,100 - 1,500ppm fluoride. However, it remains unclear if PreviDent5000 Plus has been effective in decreasing caries causing bacteria.
Background on Salivary Testing Various salivary tests have been used for years in clinical practice to determine a patient's oral bacterial load. Culturing MS from saliva in children has proven safe and valuable as part of a caries risk assessment due to the correlation between high bacterial levels and caries development. Saliva testing is relatively simple with a previous study completed at the Children's Hospital Colorado Pediatric Dentistry Clinic supporting the efficacy of several different methods for saliva collection, including directly pipetting saliva, swabbing the buccal surfaces of teeth, and stimulating saliva production with a paraffin pellet. Saliva is obtained and cultured for bacteria that are causative in caries initiation and progression, such as MS and LB. Children with a high load of MS have been shown to be 6 times more likely to develop caries and experience caries progress over a five-year period. GC Saliva-Check Mutans has been used in dental practices as a useful and simple microbial testing tool to aide providers in caries risk detection. Bacterial (MS) samples resulting in 5x10 to the 5th power colony-forming units per milliliter of saliva (CFU/mL) indicates a low caries risk. In contrast, less than 5x10 to the 5th power 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. The value of saliva testing is that it can serve as both a non-invasive diagnostic tool in determining a patient's caries risk status and a visual aide for educating parents and young patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental Caries
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Child with full primary dentition
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
GC Strep Mutans Saliva Sampling
Intervention Description
Children who match inclusion criteria will have a saliva sample obtained which will act as a proxy for bacterial levels.
Primary Outcome Measure Information:
Title
Count of Strep Mutans bacterial
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Plaque Index
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
96 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille V Gannam, DMD MS
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children'S Hospital Colorado Dental Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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).
Citations:
PubMed Identifier
23050519
Citation
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.
Results Reference
result
PubMed Identifier
27940710
Citation
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.
Results Reference
result
PubMed Identifier
27367637
Citation
Mills C, Patel P. Adopting caries risk assessment in all practice environments. Gen Dent. 2016 Jul-Aug;64(4):66-72.
Results Reference
result
PubMed Identifier
27557922
Citation
Edelstein BL, Ureles SD, Smaldone A. Very High Salivary Streptococcus Mutans Predicts Caries Progression in Young Children. Pediatr Dent. 2016;38(4):325-30. Erratum In: Pediatr Dent. 2017 Jul 15;39(4):268.
Results Reference
result
PubMed Identifier
26413427
Citation
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.
Results Reference
result
PubMed Identifier
11699977
Citation
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.
Results Reference
result
PubMed Identifier
8222603
Citation
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.
Results Reference
result
PubMed Identifier
18494159
Citation
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.
Results Reference
result
PubMed Identifier
22782050
Citation
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.
Results Reference
result
Links:
URL
http://www.aapd.org/media/policies_guidelines/g_fluoridetherapy.pdf
Description
Guideline on Fluoride Therapy
URL
http://www.aapd.org/media/policies_guidelines/g_cariesriskassessment.pdf
Description
Guideline on Caries-risk Assessment and Management for Infants, Children, and Adolescence
URL
http://www.aapd.org/media/policies_guidelines/p_eccclassifications.pdf
Description
Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options
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Microbial Testing for Caries Risk Assessment
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