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
|Condition or disease|
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|
|Actual Enrollment :||98 participants|
|Observational Model:||Case Control|
|Official Title:||Host DNA Methylation Patterns in Association With Periodontal Disease : MiRNA Changes in Obesity|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Obese group (+ periodontitis group) Non-obese group (+ periodontitis group)
DNA methylation study
Periodontitis group Healthy periodontium group
- DNA methylation patterns of selected candidate genes [ Time Frame: Visit 1 ]
- Identification of miRNA species [ Time Frame: Visit 1 ]
Biospecimen Retention: Samples With DNA
- Gingiva biopsy samples (epithelium, connective tissue)
- Gingival crevicular fluid
- Plaque samples
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): NCT01399034
|United States, North Carolina|
|Center for Oral and Systemic Diseases|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Steven Offenbacher, DDS, MS, PhD||University of North Carolina, Chapel Hill|