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NCT Number: NCT07468929

Serum Inflammatory Protein Concentration During Dental Treatment

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Graduate Periodontics Clinic

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood samples for inflammatory markers

Other

Blood samples will be obtained before the start of the procedure, the midpoint of the procedure, and the end of the procedure.

Periodontal surgery

Procedure

Periodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs

Periodontal maintenance

Procedure

Regular cleaning to maintain health after surgical treatment for periodontal disease

Non-surgical deep cleaning

Procedure

Debridement under local anesthesia, as based on treatment needs

Primary outcomes

  1. Serum CRP concentration (pg/ml)

    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.

  2. Seum IL-1 concentration (pg/ml)

    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.

  3. Serum TNF concentration (pg/ml)

    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.

Other outcomes

  1. Sedation Effect

    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.

  2. Tissue change (mm)

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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