Serum Inflammatory Protein Concentration During Dental Treatment

NCT07468929 | Not Yet Recruiting

• 1 other identifier: STUDY20252014
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Periodontal Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Sedation Effect

  Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;

• Tissue change (mm)

  Approximately 30 days after the procedure

Study Arms (3)

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; Procedure: Periodontal maintenance

Control group 2

Recruited from patients who are receiving non-surgical deep cleaning (debridement under local anesthesia)

Other: Blood samples for inflammatory markers; Procedure: Non-surgical deep cleaning

Surgical group

Recruited from patients who are treatment planned for periodontal/peri-implant surgical interventions.

Other: Blood samples for inflammatory markers; Procedure: periodontal surgery

Interventions

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.

Control group 1; Control group 2; Surgical group

periodontal surgery PROCEDURE

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

Surgical group

Periodontal maintenance PROCEDURE

Regular cleaning to maintain health after surgical treatment for periodontal disease

Control group 1

Non-surgical deep cleaning PROCEDURE

Debridement under local anesthesia, as based on treatment needs

Control group 2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Graduate Periodontics Clinic

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Binnaz Leblebibioglu, DDS, MS, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)