The Ohio State University Graduate Periodontics Clinic
Columbus, Ohio, 43210, United States
NCT Number: NCT07468929
The goal of this observational study is to study the molecular markers of stress in blood samples from people who are having periodontal surgery. The main question it aims to answer are:
* How do the levels of inflammatory molecules in the blood change during a periodontal surgery? * How are the levels of inflammatory molecules in a person having surgery different from the levels in a person having a nonsurgical procedure? * Participants will be people who are having a periodontal surgery or a nonsurgical periodontal treatment as part of their dental care. Participants will be asked to let the investigator take blood samples from them before, during, and after the procedure is being done. The blood will later be analyzed for substances in the blood that are associated with inflammation.
Trial opening soon.
Get Notified21 year–75 year
All sexes
Observational
Columbus, Ohio, 43210, United States
Periodontal disease is a chronic inflammatory disease and is associated with pro-inflammatory mediators such as increased levels of Tumor necrosis factor-alpha (TNF-a), Interleukin (IL)-17, IL-6, IL-1beta, and C-reactive protein (CRP) within gingival tissues as well as gingival crevicular fluid. IL-17 is a pro-inflammatory cytokine that promotes recruitment of neutrophil and stimulates host cells to produce other pro-inflammatory factors such as IL-1, IL-6, TNF-, and CRP that are related to the acute phase of vascular inflammation. There is evidence supporting increased levels of these mediators at diseased tooth site. Based on the severity of local periodontal inflammation, some increase in circulatory serum levels of these mediators is also expected. However, the information on how periodontal treatment performed around teeth may affect circulatory serum levels of these biologic markers is limited. Thus, this study aims to assess the acute and subacute molecular systemic effects of extensive (more than 3 adjacent teeth) periodontal/peri-implant surgery and compare them with the possible effects of non-surgical therapy (control) in patients treated for generalized form of the periodontitis
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood samples will be obtained before the start of the procedure, the midpoint of the procedure, and the end of the procedure.
Periodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs
Regular cleaning to maintain health after surgical treatment for periodontal disease
Debridement under local anesthesia, as based on treatment needs
Time frame: Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;
The investigators will study CRP concentration (pg/ml) in circulatory inflammatory mediator content during dental treatment by drawing peripheral blood samples, isolating serum and running a protein assay to detect inflammatory protein content in concentration (pg/ml) level.
Time frame: During dental procedure intervention
The investigators will measure serum IL-1 concentration (pg/ml) in blood samples obtained immediately before, during and immediately after the dental procedure.
Time frame: Blood samples will be obtained immediately before, during and immediately after dental procedure intervention.
The investigators will measure serum TNF concentration (pg/ml) during dental procedure.
Time frame: Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;
The investigators will record whether the surgical procedure was performed under sedation, and will study the possible differential effect of sedation on low level circulatory inflammation.
Time frame: Approximately 30 days after the procedure
Tissue change (mm), obtained as part of standard of care, will be collected from the participant's electronic health care record.
Ohio State University
Other
Systemic Molecular Markers of Surgical Trauma in Periodontitis/Peri-implantitis Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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