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Trial record 5 of 48 for:    gum disease AND oral | ( Map: United States ) | NIH

Epigenetics, DNA Methylation Patterns and Periodontal Disease (SZU)

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: NCT01399034
Recruitment Status : Completed
First Posted : July 21, 2011
Last Update Posted : July 21, 2011
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date July 12, 2011
First Posted Date July 21, 2011
Last Update Posted Date July 21, 2011
Study Start Date October 2007
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2011)
DNA methylation patterns of selected candidate genes [ Time Frame: Visit 1 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 20, 2011)
Identification of miRNA species [ Time Frame: Visit 1 ]
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 Epigenetics, DNA Methylation Patterns and Periodontal Disease
Official Title Host DNA Methylation Patterns in Association With Periodontal Disease : MiRNA Changes in Obesity
Brief Summary The overall goal of this research is (1) to identify changes in gene expression and DNA methylation status in subjects who exhibit advanced chronic periodontal inflammation and (2) to identify microRNAs (miRNAs) and the interactive pathways associated with obesity as a modifier of periodontal infection pathogenesis.
Detailed Description

Aim 1. To determine whether diseased periodontal tissues biopsied from patients with periodontal disease will have altered DNA methylation patterns of selected genes as compared to the DNA methylation status biopsies obtained from adjacent, non-diseased periodontal sites, as well as periodontal biopsy samples obtained from non-diseased, healthy subjects.

Aim 2. To determine the role of tissue DNA Methylation on mRNA expression:

  • 2a. To determine whether alterations in tissue mRNA expression (as determined by quantitative PCR) are associated with an aberrant DNA methylation status of respective gene promoter CpG islands in tissue biopsy samples obtained from diseased and non-diseased tissues from patients with periodontal disease and from non-diseased healthy subjects.
  • 2b. By performing laser capture microdissection of biopsy samples from diseased patients [(epithelium, connective tissue and inflammatory infiltrate)] we seek to determine cellular patterns of mRNA expression and DNA methylation of targeted genes comparing inflamed to non-inflamed sites within diseased patients.
  • 2c. We will perform in vitro studies to analyze whether gingival fibroblasts from patients with periodontal disease will show a differential methylation pattern and whether these cells will display a differential inflammatory response when compared to control fibroblasts isolated from healthy subjects.

Aim 3. The aim of this pilot investigation was to determine if miRNA expression differed in the presence or absence of obesity, comparing gingival biopsies obtained from patients with or without periodontal disease.

  • 3a. To determine whether diseased periodontal tissues biopsied from patients with periodontal disease will influence the level of miRNA expression as compared to the biopsies obtained from non-diseased, healthy subjects.
  • 3b. To determine whether BMI [nonobese subjects BMI <30kg/m2, obese subjects >30kg/m2] will influence the level of miRNA expression in biopsies from diseased periodontal tissues as compared to periodontal biopsy samples obtained from non-diseased, healthy subjects.

Gingival samples, gingival crevicular fluid, saliva and plaque samples will be collected and a periodontal examination will be performed. The periodontal assessment will record pocket depth, clinical attachment level and percent bleeding on probing. Blood pressure, height and weight (Body Mass Index assessment) will be obtained on participants as well.

Tissue gene expression by quantitative PCR and DNA methylation sequence analysis, proteomic analyses of gingival crevicular fluid, Differential Methylation Hybridization and, microRNA expression profile by Human miRNA Microarray and Real-time PCR quantification will all be performed.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • Gingiva biopsy samples (epithelium, connective tissue)
  • Gingival crevicular fluid
  • Saliva
  • Plaque samples
Sampling Method Probability Sample
Study Population Ninety-eight subjects will be recruited from the Graduate Periodontics Clinic and Dental Faculty Practice at the University of North Carolina School of Dentistry and if needed from the general population. Subjects must present with either chronic periodontitis or periodontal health.
Condition Periodontal Disease
Intervention Not Provided
Study Groups/Cohorts
  • MicroRNA study
    Obese group (+ periodontitis group) Non-obese group (+ periodontitis group)
  • DNA methylation study
    Periodontitis group Healthy periodontium group
Publications * Not Provided

*   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: July 20, 2011)
98
Original Actual Enrollment Same as current
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects must be adult males or females between the ages of 18 and 65 years (inclusive).
  • Subjects must be able and willing to follow study procedures and instructions.
  • Subjects must have read, understood and signed an informed consent form.
  • Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.
  • Subjects must be in good general health.
  • Subjects must present with advanced chronic periodontitis (American Dental Association Class 4) as determined by the investigator or designee during the screening periodontal examination. Such subjects will exhibit periodontal pocketing (>5 mm and Bleeding on Probing) and severe alveolar bone loss. Subjects will be under active care for periodontitis and will be treatment planned for periodontal flap surgery.
  • Control subjects must present with periodontal health as determined by the investigator or designee during the screening periodontal examination. Such subjects will exhibit no evidence of periodontal pocketing (pockets ≤4mm), and no bleeding on probing at the site of the biopsy. Patients from this group will be treatment planned for routine crown extension procedures for restorative reasons, or be volunteers from the general population meeting the inclusion criteria.
  • 24 subjects from group 2 will be enrolled based on Body Mass Index (BMI). Twelve obese subjects (BMI of 30 or greater) and twelve non-obese subjects (BMI less than 30) will be enrolled. Twelve from the obese and twelve from the non-obese group will be split in half based on periodontal status.
  • 6 periodontal healthy non-obese
  • 6 periodontal healthy obese
  • 6 periodontal diseased non-obese
  • 6 periodontal diseased obese

Exclusion Criteria:

  • Individuals who have a chronic disease with oral manifestations.
  • Individuals who exhibit gross oral pathology.
  • Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
  • Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination.
  • Ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
  • Subjects with clinically significant organ disease including impaired renal function, or any bleeding disorder.
  • Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis.
  • Severe unrestored caries, or any condition that is likely to require antibiotic treatment over the trial, including the need for prophylactic antibiotic
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (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 NCT01399034
Other Study ID Numbers 07-0749
1R01DE021052-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Steven Offenbacher, DDS, MS, PhD, Center for Oral and Systemic Diseases
Study Sponsor University of North Carolina, Chapel Hill
Collaborators National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Steven Offenbacher, DDS, MS, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date July 2011