Periodontal DiseaseNCT07468929
Serum Inflammatory Protein Concentration During Dental Treatment
An observational study of Periodontal Disease and Periodontal Surgery, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Periodontal Disease, Periodontal Surgery
- What is being tested?
- Blood samples for inflammatory markers, periodontal surgery and Periodontal maintenance
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults 21-75 years of age
- Systemically healthy
- Non-smoker
- scheduled to receive nonsurgical or surgical periodontal treatment under IV sedation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Graduate Periodontics Clinic
Columbus, Ohio, 43210
Binnaz Leblebicioglu, DDS, MS, PhD, 614-292-0371, leblebicioglu.1@osu.edu
About this study
Official title: 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.
Read the 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
- Conditions
- Periodontal Disease, Periodontal Surgery
- Being tested
- Blood samples for inflammatory markers, periodontal surgery, Periodontal maintenance, Non-surgical deep cleaning
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for inflammatory markersOther
Blood samples will be obtained before the start of the procedure, the midpoint of the procedure, and the end of the procedure.
periodontal surgeryProcedure or surgery
Periodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs
Periodontal maintenanceProcedure or surgery
Regular cleaning to maintain health after surgical treatment for periodontal disease
Non-surgical deep cleaningProcedure or surgery
Debridement under local anesthesia, as based on treatment needs
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: 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. Receives: Other: Blood samples for inflammatory markers; Procedure: periodontal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During dental procedure intervention
Serum TNF concentration (pg/ml)
The investigators will measure serum TNF concentration (pg/ml) during dental procedure.
Measured: Blood samples will be obtained immediately before, during and immediately after dental procedure intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start13 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binnaz Leblebicioglu, Ohio State University
- Investigators
- Binnaz Leblebibioglu, DDS, MS, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468929
- Sponsor's protocol ID
- STUDY20252014
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Molecular Markers of Surgical Trauma in Periodontitis/Peri-implantitis Patients
- ClinicalTrials.gov ID
- NCT07468929
- Acronym / sponsor ID
- STUDY20252014
- Conditions
- Periodontal Disease, Periodontal Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group 1 | – | Other: Blood samples for inflammatory markers, Procedure: Periodontal maintenanceRecruited from patients who have already received active treatment to control their disease and are now in periodontal maintenance program (regular cleaning). |
| Control group 2 | – | Other: Blood samples for inflammatory markers, Procedure: Non-surgical deep cleaningRecruited from patients who are receiving non-surgical deep cleaning (debridement under local anesthesia) |
| Surgical group | – | Other: Blood samples for inflammatory markers, Procedure: periodontal surgeryRecruited from patients who are treatment planned for periodontal/peri-implant surgical interventions. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults 21-75 years of age
- Systemically healthy
- Non-smoker
- scheduled to receive nonsurgical or surgical periodontal treatment under IV sedation
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for inflammatory markersBlood samples will be obtained before the start of the procedure, the midpoint of the procedure, and the end of the procedure. | Other | Control group 1, Control group 2, Surgical group |
| periodontal surgeryPeriodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs | Procedure or surgery | Surgical group |
| Periodontal maintenanceRegular cleaning to maintain health after surgical treatment for periodontal disease | Procedure or surgery | Control group 1 |
| Non-surgical deep cleaningDebridement under local anesthesia, as based on treatment needs | Procedure or surgery | Control group 2 |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Graduate Periodontics Clinic
Columbus, United States
Binnaz Leblebibioglu, DDS, MS, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease and Periodontal Surgery, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CRP concentration (pg/ml) (time frame: Immediately prior to procedure; approximately midway through the procedure; immediately after procedure ends;). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.