Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Stopped early

Conditions studied: Gingivitis, Periodontal Disease

In brief

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.

Key facts

Study ID

NCT02403297

Run by

Innovative Diagnostics Inc

People needed

93

Starts

2015-03-01

Expected to finish

2016-05-01

Last updated by the study team

2016-08-17

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Innovative Diagnostics Inc — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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