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NCT01663298 · ClinicalTrials.gov registry record
Gene Expression Variation and Implant Wound Healing Among Smokers and Diabetics
A clinical trial of Diabetes and Smoking, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 44
- Enrollment target
- 1
- Study location
NCT01663298: Completed study of Diabetes and Smoking, sponsored by University of North Carolina, Chapel Hill.
NCT01663298 is a study of Diabetes and Smoking that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 44 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01663298, a study of Diabetes and Smoking, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Genomic DNA is isolated from the collected gingival tissue samples. Methylation alterations in FGF2 are detected through differential methylation hybridization using the EpiTect® Methyl qPCR single assay.
Interventions
- PROCEDURE Dental implant surgery
Study Locations (1)
North Carolina
- Department of Periodontology, UNC School of Dentistry - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-08 |
| Est. Completion | 2016-02-23 |
What the finished NCT01663298 record still lists
NCT01663298 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Dental implant surgery is the first listed.
NCT01663298 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01663298 about?
NCT01663298 is a clinical study titled "Gene Expression Variation and Implant Wound Healing Among Smokers and Diabetics". 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...
What is the current status of trial NCT01663298?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2010-08. Estimated completion is 2016-02-23.
What conditions does trial NCT01663298 study?
This clinical trial studies the following conditions: Diabetes, Smoking.
What interventions are being tested in trial NCT01663298?
The interventions under investigation include: Dental implant surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01663298?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01663298 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01663298's enrollment target sits among peer trials
44 257th of 338 higher than 80 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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