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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007735
Enrollment
300
Registered
2022-09-23
Start date
2022-02-08
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Seoul National University Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
salivary MMP-8 level

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactHYUNYOUNG SONG

Seoul National University Dental Hospital

1030shy@naver.com+82-2-2072-3071

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026