Gene Expression Variation and Implant Wound Healing Among Smokers and Diabetics

Completed

Conditions studied: Smoking, Diabetes

In brief

Periodontal wound healing is a complex multifactorial process that involves interactions among various cells, growth factors, hormones and extracellular matrices. Although still poorly understood, these interactions trigger a series of events that lead to new tissue formation. One growth factor that plays an important role in wound healing is fibroblast growth factor 2 (FGF2). Many animal and human studies have shown this protein is effective in periodontal regeneration. Recently, epigenetic modifications, such as DNA methylation, have been associated with changes in patterns of gene expression. Preliminary data suggests that FGF2 gene may be differentially methylated in periodontal tissues. Aberrant gene promoter methylation in smokers and diabetics has also been reported in many studies. However, the role of DNA methylation in wound healing has not yet been investigated. The investigators hypothesize that the methylation status of FGF2 gene can affect the levels of FGF2 secreted during wound healing phase after dental implant surgery. The investigators also hypothesize there exists a difference in methylation levels of FGF2 gene in healthy, smoking and diabetic patients that can interfere with wound healing. The investigators seek to determine whether DNA methylation plays a role in wound healing and whether the methylation level of FGF2 gene varies among healthy, smoking and diabetic patients.

Key facts

Study ID

NCT01663298

Run by

University of North Carolina, Chapel Hill

People needed

44

Starts

2010-08-01

Expected to finish

2016-02-23

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult males or females between the age of 18 and 70 years (inclusive)
• Able and willing to follow study procedures and instructions
• Have read, understood and signed an informed consent form
• In good general health
• Have one or more implant placements as their future treatment needs. The implant placement can be either as one-stage or two-stage, and can be either in an edentulous ridge or an extraction socket
• Qualify for enrollment into one of the three study groups
• Have probing depth ≤ 4 mm for all teeth at the same quadrant of implant placement. Sites with probing depth 5 mm will also be included if bleeding on probing in these sites are absent.

You may not qualify if…

• Have a chronic disease with oral manifestations
• Exhibit gross oral pathology
• Use of either antibiotics or NSAIDs within 1 month prior to 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) within 1 month prior to screening examination
• Systemic conditions, except smoking and diabetes, that are known to affect the periodontal status
• With active infectious diseases such as hepatitis, HIV or tuberculosis
• Known to be pregnant or breastfeeding

Where it is running

• Department of Periodontology, UNC School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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