Serum Inflammatory Protein Concentration During Dental Treatment

Официальное название

Systemic Molecular Markers of Surgical Trauma in Periodontitis/Peri-implantitis Patients

Обзор

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.

Подробное описание

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

Вмешательства

• Другое Blood samples for inflammatory markers
  Blood samples will be obtained before the start of the procedure, the midpoint of the procedure, and the end of the procedure.
• Процедура periodontal surgery
  Periodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs
• Процедура Periodontal maintenance
  Regular cleaning to maintain health after surgical treatment for periodontal disease
• Процедура Non-surgical deep cleaning
  Debridement under local anesthesia, as based on treatment needs

Первичные конечные точки

• Serum CRP concentration (pg/ml) [Срок оценки: Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;]
• Seum IL-1 concentration (pg/ml) [Срок оценки: During dental procedure intervention]
• Serum TNF concentration (pg/ml) [Срок оценки: Blood samples will be obtained immediately before, during and immediately after dental procedure intervention.]

Критерии участия

Критерии включения

• Adults 21-75 years of age
• Systemically healthy
• Non-smoker
• scheduled to receive nonsurgical or surgical periodontal treatment under IV sedation

Критерии исключения

• Patients who have localized form of the disease (less than 30% of available tooth/implant sites are affected with the disease)
• Non-english speaking individuals since informed consent form will be in English only.
• Patients with uncontrolled systemic diseases (such as metabolic diseases, obesity, diabetes, high blood pressure) since these types of chronic inflammatory challenges would cause increase levels of circulatory serum pro-inflammatory markers.
• Pregnant patients (pregnancy will be reported by the patient) since pregnancy itself would affect circulatory serum pro-inflammatory markers.
• Patients who are not willing to have blood drawing for the study purpose.
• Patients who are not willing to sign research related consent form.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• The Ohio State University Graduate Periodontics Clinic — Columbus

Идентификаторы

NCT: NCT07468929 · STUDY20252014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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