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The Importance of Periostin in Periodontal Health and Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180920
First Posted: August 12, 2010
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Hector Rios, University of Michigan
  Purpose
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.

Condition
Periodontal Disease Non-diseased Patients

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Importance of Periostin in Periodontal Health and Disease

Resource links provided by NLM:


Further study details as provided by Hector Rios, University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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.

Enrollment: 22
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will have a sample size of 22 subjects: 11 periodontally healthy and 11 with periodontal disease.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180920


Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Hector Rios, MS, DDS University of Michigan
Study Director: William V Giannobile, DDS, DMSc University of Michigan
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hector Rios, Assistant Professor of Periodontal and Oral Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01180920     History of Changes
Other Study ID Numbers: HUM00038150
5K23DE019872 ( U.S. NIH Grant/Contract )
First Submitted: August 10, 2010
First Posted: August 12, 2010
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Hector Rios, University of Michigan:
Dental
Periodontal
Surgery
Gums

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases