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Trial record 6 of 46 for:    gum disease | NIH

The Importance of Periostin in Periodontal Health and Disease

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ClinicalTrials.gov Identifier: NCT01180920
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : December 2, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Hector Rios, University of Michigan

August 10, 2010
August 12, 2010
December 2, 2014
June 2011
February 2013   (Final data collection date for primary outcome measure)
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 ]
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.
Same as current
Complete list of historical versions of study NCT01180920 on ClinicalTrials.gov Archive Site
explore the expression dynamics of Periostin during periodontal healing in healthy and diseased periodontia. [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
The Importance of Periostin in Periodontal Health and Disease
The Importance of Periostin in Periodontal Health and Disease
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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.
Non-Probability Sample
This study will have a sample size of 22 subjects: 11 periodontally healthy and 11 with periodontal disease.
  • Periodontal Disease
  • Non-diseased Patients
Not Provided
  • Periodontal disease
    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
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Same as current
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01180920
HUM00038150
5K23DE019872 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Hector Rios, University of Michigan
University of Michigan
  • National Institutes of Health (NIH)
  • National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Hector Rios, MS, DDS University of Michigan
Study Director: William V Giannobile, DDS, DMSc University of Michigan
University of Michigan
December 2014