The Importance of Periostin in Periodontal Health and Disease
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Importance of Periostin in Periodontal Health and Disease|
- 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. [ Time Frame: Baseline ] [ Designated as safety issue: No ]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.
- explore the expression dynamics of Periostin during periodontal healing in healthy and diseased periodontia. [ Time Frame: 8wks ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Each patient will be have 5ml of blood collected at 3 different visits. Saliva, and gingival crevicular fluid will also be collected at 7-8 visits during the study. Gingival tissue will be collected on the day of surgery.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180920
|Contact: Lea M Franco, MS, BS||(734) 998 - email@example.com|
|Contact: Anna M Galloro, BS, MT||(734) 998 - firstname.lastname@example.org|
|United States, Michigan|
|Michigan Center for Oral Health Research||Recruiting|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator: Hector Rios, MS, DDS|
|Principal Investigator:||Hector Rios, MS, DDS||University of Michigan|
|Study Director:||William V Giannobile, DDS, DMSc||University of Michigan|