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Serum Inflammatory Protein Concentration During Dental Treatment

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07468929
Enrollment
30
Registered
2026-03-13
Start date
2026-02-01
Completion date
2027-02-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease, Periodontal Surgery

Brief summary

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.

Detailed 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

Interventions

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

PROCEDUREPeriodontal maintenance

Regular cleaning to maintain health after surgical treatment for periodontal disease

PROCEDURENon-surgical deep cleaning

Debridement under local anesthesia, as based on treatment needs

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum CRP concentration (pg/ml)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.
Seum IL-1 concentration (pg/ml)During dental procedure interventionThe investigators will measure serum IL-1 concentration (pg/ml) in blood samples obtained immediately before, during and immediately after the dental procedure.
Serum TNF concentration (pg/ml)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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBinnaz Leblebibioglu, DDS, MS, PhD

Ohio State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026