Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Terminated

• Conditions: Periodontal Disease; Gingivitis
• Interventions: Device: Quik Check PD

• 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

Arm && Interventions

Group	Intervention	Description
Healthy	Quik Check PD	Saliva will be collected from 58 subjects determined to be "healthy" according to the protocol.
Gingivitis	Quik Check PD	Saliva will be collected from 58 subjects determined to have gingivitis according to the protocol.
Periodontal disease	Quik Check PD	Saliva will be collected from 58 subjects determined to have periodontal disease according to the protocol.

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