Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Gingivitis Clinical Trial

Official title:

Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02403297
• Other study ID #: 2013-1R43DE024015-01
• Status: Terminated
• Phase: N/A
• First received: March 23, 2015
• Last updated: August 16, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Innovative Diagnostics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Periodontal Disease
• Periodontal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Innovative Diagnostics Inc	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Diagnostics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of MMP-8 in the subjects saliva using the Quik Check PD device		One day. Subjects complete the study in 45 minutes.	No
Secondary	Amount of MMP-8 in the subjects saliva sample using Luminex Analysis		One day. Subjects complete the study in 45 minutes.	No