The Importance of Periostin in Periodontal Health and Disease

Completed

• Conditions: Non-diseased Patients; Periodontal Disease

• Registration Number: NCT01180920
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Study Start: 2011-06
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether the expression of Periostin within the periodontal tissues is affected in periodontal disease progression in-vivo and whether Periostin levels are associated with disease susceptibility.	Baseline	Periostin levels from gingival crevicular fluid (GCF), saliva, serum and tissue will be analyzed in both health and disease. Total RNA and protein extracts will be isolated and utilized for relative quantitative measurements.

Secondary Outcome Measures

Name	Time	Method
explore the expression dynamics of Periostin during periodontal healing in healthy and diseased periodontia.	8wks	A longitudinal study will also be performed to evaluate Periostin levels in GCF/wound fluids and saliva over time during periodontal tissue healing and homeostasis.

Trial Locations

Locations (1)

Michigan Center for Oral Health Research; 🇺🇸 Ann Arbor, Michigan, United States