Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Terminated

• Conditions: Periodontal Disease; Gingivitis

• Registration Number: NCT02403297
• Lead Sponsor: Innovative Diagnostics Inc

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Primary Completion: 2015-11
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of MMP-8 in the subjects saliva using the Quik Check PD device	One day. Subjects complete the study in 45 minutes.

Secondary Outcome Measures

Name	Time	Method
Amount of MMP-8 in the subjects saliva sample using Luminex Analysis	One day. Subjects complete the study in 45 minutes.

Trial Locations

Locations (1)

Innovative Diagnostics Inc; 🇺🇸 Lexington, Kentucky, United States