Serum Inflammatory Protein Concentration During Dental Treatment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Disease; Periodontal Surgery
• Intervention / Treatment: Other: Blood samples for inflammatory markers; Procedure: Periodontal maintenance; Procedure: Non-surgical deep cleaning; Procedure: periodontal surgery

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

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Graduate Periodontics Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population will be created from the general patient population that is referred to The Ohio State University College of Dentistry's Advanced Training in Periodontology clinics or already established patients in our clinics. These are adult patients suffering from gum disease, losing teeth due to disease and/or having disease around their dental implants. There will be two groups: Control group 1 will be recruited from the patients who have already received active treatment to control their disease and are now in periodontal maintenance program (regular cleaning). Control group 2 will be recruited from patients who are receiving non-surgical deep cleaning (debridement under local anesthesia) and Test group will be recruited from patients who are treatment planned for periodontal/peri-implant surgical interventions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group 2; Recruited from patients who are receiving non-surgical deep cleaning (debridement under local anesthesia)	Other: 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.; Procedure: Non-surgical deep cleaning; Debridement under local anesthesia, as based on treatment needs
Surgical group; Recruited from patients who are treatment planned for periodontal/peri-implant surgical interventions.	Other: 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.; Procedure: periodontal surgery; Periodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs
Control group 1; Recruited from patients who have already received active treatment to control their disease and are now in periodontal maintenance program (regular cleaning).	Other: 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.; Procedure: Periodontal maintenance; Regular cleaning to maintain health after surgical treatment for periodontal disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum CRP concentration (pg/ml)	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.	Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;
Seum IL-1 concentration (pg/ml)	The investigators will measure serum IL-1 concentration (pg/ml) in blood samples obtained immediately before, during and immediately after the dental procedure.	During dental procedure intervention
Serum TNF concentration (pg/ml)	The investigators will measure serum TNF concentration (pg/ml) during dental procedure.	Blood samples will be obtained immediately before, during and immediately after dental procedure intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue change (mm)	Tissue change (mm), obtained as part of standard of care, will be collected from the participant's electronic health care record.	Approximately 30 days after the procedure
Sedation Effect	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.	Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Binnaz Leblebibioglu, DDS, MS, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: STUDY20252014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No