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Trial record 3 of 48 for:    gum disease AND oral | ( Map: United States ) | NIH

The Importance of Periostin in Periodontal Health and Disease

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.
 
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

Tracking Information
First Submitted Date August 10, 2010
First Posted Date August 12, 2010
Last Update Posted Date December 2, 2014
Study Start Date June 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2010)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01180920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 11, 2010)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Importance of Periostin in Periodontal Health and Disease
Official Title The Importance of Periostin in Periodontal Health and Disease
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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
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.
Condition
  • Periodontal Disease
  • Non-diseased Patients
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 11, 2010)
22
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01180920
Other Study ID Numbers HUM00038150
5K23DE019872 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hector Rios, University of Michigan
Study Sponsor University of Michigan
Collaborators
  • 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
PRS Account University of Michigan
Verification Date December 2014