Serum Inflammatory Protein Concentration During Dental Treatment

September 9, 2026 updated by: Binnaz Leblebicioglu, Ohio State University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;
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.
During dental procedure intervention
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.
Blood samples will be obtained immediately before, during and immediately after dental procedure intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 30 days after the procedure
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.
Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Binnaz Leblebibioglu, DDS, MS, PhD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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