Clinical trial NCT02403297: Rapid Point-of-Care Salivary Diagnostic for Periodontal Health
Official title: Rapid Point-of-Care Salivary Diagnostic for Periodontal Health
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gingivitis
Periodontal Disease
Keywords: Bleeding gums
Gum inflammation
Saliva
Lead sponsor: Innovative Diagnostics Inc
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of MMP-8 in the subjects saliva using the Quik Check PD device
timeFrame: One day. Subjects complete the study in 45 minutes.
Secondary outcomes:
measure: Amount of MMP-8 in the subjects saliva sample using Luminex Analysis
timeFrame: One day. Subjects complete the study in 45 minutes.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Innovative Diagnostics Inc
state: Kentucky
Study officials:
References: