Epigenetics, DNA Methylation Patterns and Periodontal Disease

NCT01399034 | Completed

• 2 other identifiers: 07-07491R01DE021052-01
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease

Keywords

Epigenomics; DNA methylation; MicroRNA; Periodontitis; Inflammation; Obesity

Outcome Measures

Primary Outcomes (1)

• DNA methylation patterns of selected candidate genes

  Visit 1

Secondary Outcomes (1)

• Identification of miRNA species

  Visit 1

Study Arms (2)

MicroRNA study

Obese group (+ periodontitis group) Non-obese group (+ periodontitis group)

DNA methylation study

Periodontitis group Healthy periodontium group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• periodontal healthy non-obese
• periodontal healthy obese
• periodontal diseased non-obese
• periodontal diseased obese

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Center for Oral and Systemic Diseases

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Gingiva biopsy samples (epithelium, connective tissue) * Gingival crevicular fluid * Saliva * Plaque samples

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Inflammation; Obesity

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Steven Offenbacher, DDS, MS, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 21, 2011
• Study Start: October 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

US (1)