Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

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.

Study Overview

• Status: Terminated
• Conditions: Gingivitis; Periodontal Disease
• Intervention / Treatment: Device: Quik Check PD

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 Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Innovative Diagnostics Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Saliva will be collected from 58 subjects determined to be "healthy" according to the protocol.	Device: Quik Check PD; 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.	Device: Quik Check PD; 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.	Device: Quik Check PD; The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Innovative Diagnostics Inc

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Saliva; Gum inflammation; Bleeding gums
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Periodontal Diseases
• Other Study ID Numbers: 2013-1R43DE024015-01