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Serum Inflammatory Protein Concentration During Dental Treatment

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The Ohio State University

Status

Not yet enrolling

Conditions

Periodontal Surgery
Periodontal Disease

Treatments

Procedure: periodontal surgery
Procedure: Non-surgical deep cleaning
Other: Blood samples for inflammatory markers
Procedure: Periodontal maintenance

Study type

Observational

Funder types

Other

Identifiers

NCT07468929
STUDY20252014

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

30 participants in 3 patient groups

Control group 1
Description:
Recruited from patients who have already received active treatment to control their disease and are now in periodontal maintenance program (regular cleaning).
Treatment:
Procedure: Periodontal maintenance
Other: Blood samples for inflammatory markers
Control group 2
Description:
Recruited from patients who are receiving non-surgical deep cleaning (debridement under local anesthesia)
Treatment:
Other: Blood samples for inflammatory markers
Procedure: Non-surgical deep cleaning
Surgical group
Description:
Recruited from patients who are treatment planned for periodontal/peri-implant surgical interventions.
Treatment:
Other: Blood samples for inflammatory markers
Procedure: periodontal surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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