Diagnostic Accuracy of Periodontitis with Point of Care Test Device INCLIXTM TRF MMP-8 using Human Saliva: A Single Center, Single Blinded, Pivotal Study

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0007735
• Lead Sponsor: Seoul National University Dental Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-14
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1) subjects with 20 or more natural teeth
2) subjects aged between 19 and 89 and voluntarily participated in this study

Exclusion Criteria

1)subjects having received periodontal therapy within the previous 4 months.
2) Subjects who have taken antibiotics within the previous 3 months.
3) Subjects using immunosuppressants (methotrexate, leflunomide, tacrolimus, cyclosporin, azathioprine) or corticosteroids (oral or injection) within previous 3 months.
4) Subjects with uncontrolled hypertension or diabetes.
5) Subjects with serious cardiovascular disease, respiratory system disease, kidney disease, liver disease, digestive system disease, blood system disease, and/or neuropsychiatric disease complications.
6) Subjects with hyperthyroidism or hypothyroidism.
7) pregnancy.
8) Subjects with autoimmune diseases.
9) Subjects with a history or current malignant tumors in the maxilla or mandible.
10) Subjects who have had or are current drugs abuse or alcohol addiction within previous 1 year.
11) Subjects with ulcerative, bullous, or erosive stomatitis.
12) Subjects with other inflammatory diseases in oral cavity, such as canker sores, herpes simplex and herpes zoster, fungal or bacterial infections except periodontitis.

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
salivary MMP-8 level

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth, gingival recession, clinical attachment level, gingival index, plaque index), tooth loss, bleeding on probing, tooth mobility, furcation involvement, Alveolar bone loss at the mesial and distal