The Importance of Periostin in Periodontal Health and Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01180920
First received: August 10, 2010
Last updated: September 3, 2010
Last verified: September 2010
  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
Healthy Patients

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

Further study details as provided by 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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 22
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)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180920

Contacts
Contact: Lea M Franco, MS, BS (734) 998 - 6721 mcohrclinicalresearch@umich.edu
Contact: Anna M Galloro, BS, MT (734) 998 - 6721 mcohrclinicalresearch@umich.edu

Locations
United States, Michigan
Michigan Center for Oral Health Research Recruiting
Ann Arbor, Michigan, United States, 48106
Principal Investigator: Hector Rios, MS, DDS         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Hector Rios, MS, DDS University of Michigan
Study Director: William V Giannobile, DDS, DMSc University of Michigan
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Principal Investigator: Hector Rios, MS, DDS, University of Michigan
ClinicalTrials.gov Identifier: NCT01180920     History of Changes
Other Study ID Numbers: HUM00038150
Study First Received: August 10, 2010
Last Updated: September 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Dental
Periodontal
Surgery
Gums

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 19, 2014