Rapid Point-of-Care Salivary Diagnostic for Periodontal Health
| Status: | Terminated |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - 95 |
| Updated: | 8/18/2016 |
| Start Date: | March 2015 |
| End Date: | May 2016 |
The purpose of this study is to learn if a chair-side testing device will accurately measure
levels of a salivary biomarker and thus indicate if a patient has periodontal health,
gingivitis or periodontal disease.
levels of a salivary biomarker and thus indicate if a patient has periodontal health,
gingivitis or periodontal disease.
Human subjects will participate in this cross-sectional study by attending a single visit
where their mouth will be examined and saliva will be collected to help determine the
accuracy of a POC salivary diagnostic device. The study population will consist of 174
persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis;
and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be
compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2)
discriminant analysis that examines whether the concentration would correctly identify the
subject as health or disease using a defined threshold for MMP-8 levels.
Three groups of individuals will be recruited: those that are orally healthy and do not have
any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those
who have periodontal disease (N=58). The groups will be matched by gender and smoking
status. Women are predicted to account for 50% of the participants. The age distribution
will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.
where their mouth will be examined and saliva will be collected to help determine the
accuracy of a POC salivary diagnostic device. The study population will consist of 174
persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis;
and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be
compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2)
discriminant analysis that examines whether the concentration would correctly identify the
subject as health or disease using a defined threshold for MMP-8 levels.
Three groups of individuals will be recruited: those that are orally healthy and do not have
any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those
who have periodontal disease (N=58). The groups will be matched by gender and smoking
status. Women are predicted to account for 50% of the participants. The age distribution
will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.
Inclusion Criteria:
- Males or females of all racial and ethnic groups over 18 years of age;
- At least 20 erupted teeth and the ability to provide expectorated saliva;
- Able and willing to comply with study requirements; and
- Have full understanding of all elements of, and signature and dating of the written
informed consent prior to the initiation of protocol specified procedures
Exclusion Criteria:
- Prisoners or institutionalized individuals;
- Persons with acute illness or infectious disease (as evidenced by fever, malaise,
sore throat, recurrent cough, lymphadenopathy, swelling and/or a physician
consultation);
- Evidence of oral mucosal lesion or ulceration; or
- Use of glucocorticoids or cyclooxygenase inhibitors (i.e. such as ibuprofen,
Naprosyn(Aleve) or non-steroidal anti-inflammatory drug) daily for the past two
weeks.
We found this trial at
1
site
Click here to add this to my saved trials
