Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

NCT ID: NCT02403297

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Gingivitis; Periodontal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy

Saliva will be collected from 58 subjects determined to be "healthy" according to the protocol.

Quik Check PD

Intervention Type: DEVICE

The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.

Gingivitis

Saliva will be collected from 58 subjects determined to have gingivitis according to the protocol.

Quik Check PD

Intervention Type: DEVICE

The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.

Periodontal disease

Saliva will be collected from 58 subjects determined to have periodontal disease according to the protocol.

Quik Check PD

Intervention Type: DEVICE

The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.

Interventions

Quik Check PD

The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innovative Diagnostics Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Innovative Diagnostics Inc

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

2013-1R43DE024015-01

Identifier Type: -

Identifier Source: org_study_id