The Importance of Periostin in Periodontal Health and Disease

University of Michigan

Status: Completed

Conditions: Non-diseased Patients; Periodontal Disease

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01180920

HUM00038150

5K23DE019872 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to determine the clinical importance of Periostin in oral health and disease. The long-term goal will be to develop practical applications for the diagnosis, treatment, prevention and cure of human periodontal diseases.

Full description

It is hypothesized that Periostin levels are decreased during periodontal diseases, thereby, elevating the hosts' susceptibility to periodontal breakdown. The specific aims are the following; To determine if Periostin is a biomarker of periodontal disease, and To evaluate Periostin in periodontal tissue healing and homeostasis by harvesting healthy or diseased tissue from 22 patients requiring periodontal surgery.

Enrollment: 22 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria for diseased subjects:

• Diagnosis of generalized chronic or aggressive periodontitis
• At least four periodontal sites with probing depth (PD) ≥6 mm, evidence of clinical attachment loss (CAL), and bleeding on probing (BOP). Inclusion criteria for healthy individuals will include PD <4 mm, no evidence of attachment loss, and <10% of sites with BOP
• Need an open flap procedure

Inclusion criteria for non-diseased subjects:

• Subjects requiring a gingivectomy or crown lengthening procedure

Exclusion criteria

• History of alcoholism or drug abuse
• Medical conditions that may affect the outcome such as autoimmune diseases, diabetes, immunocompromised subjects, neurologic or psychiatric disorders, systemic infections, etc.
• Chronic medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications, Depo-Provera contraceptive injection users, new oral contraceptives users within 3 months of baseline or subjects that are planning on, starting oral contraceptives during the study.
• Antibiotic therapy within 3 months of the baseline visit, and/or antibiotic therapy needed for infective endocarditis prophylaxis.
• Current use or quit smoking less than one year ago with a pack-year history of more than or equal to 10.
• Untreated cavities

Trial design

22 participants in 2 patient groups

Periodontal disease

Description:

11 patients with periodontal disease, specifically generalized chronic or aggressive periodontitis will be selected. In general, the disease group will be comprised of subjects that need an open flap procedure.

Healthy periodontium

Description:

11 patients without periodontal disease will be selected. In general, the healthy group will be comprised of subjects that are requiring a gingivectomy or crown lengthening procedure.