ClinicalTrials.gg
RecruitingNCT07468929Updated Sep 11, 2026

Serum Inflammatory Protein Concentration During Dental Treatment

An observational study in Periodontal Disease and Periodontal Surgery, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Ohio State University · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
21 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 91 studies in Periodontal Diseases with a site in United States — 15 open to participants now, 17 under way, none of them phase 3. Periodontal Diseases · United States.

Planned enrollment
24th of 30
30 · median 89
Started
2026
with 2 others
Observational
30 of 91
5 open now
Primary completion
2027-06
later than 10 of 15 live
Registered
90th of 91
by date

Among the 91 studies in Periodontal Diseases with a site in United States, this one is the 24th largest by planned enrollment of the 30 observational ones that give a count, is one of 3 that started in 2026, is one of 30 observational ones, reaches primary completion later than 10 of the 15 other live ones, and was the 90th registered.

Periodontal Diseases

867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

Browse Periodontal Diseases studies →

Open to participants now

15 of the 91 studies in Periodontal Diseases with a site in United States are open now. Recruiting first, the newest first:

9 more — sign in →

All 15 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 101 Periodontal Diseases studies recruiting now, 47 (47%) set no upper age limit and 42 (42%) stop at 75 or younger; 5 take children under 18; 58 take healthy volunteers.

This study: 21 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.
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

03

Conditions studied

  • Periodontal Disease
  • Periodontal Surgery

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04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherBlood 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.

  • Procedureperiodontal surgery

    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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    Time frame: During dental procedure intervention

  3. Serum TNF concentration (pg/ml)

    The investigators will measure serum TNF concentration (pg/ml) during dental procedure.

    Time frame: Blood samples will be obtained immediately before, during and immediately after dental procedure intervention.

Other outcomes

  1. 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.

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

  2. Tissue change (mm)

    Tissue change (mm), obtained as part of standard of care, will be collected from the participant's electronic health care record.

    Time frame: Approximately 30 days after the procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.

Of 79 non-industry observational studies under Periodontal Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 11 months is below that.

Counting every sponsor, half of 83 studies reached it within 13 months; a quarter within 7 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2026
First posted
Mar 13, 2026
StartActual
Jul 13, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07468929
Responsible party
Binnaz Leblebicioglu (Professor, Ohio State University) — Principal investigator
First posted
Mar 13, 2026
Start date
Jul 13, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Binnaz Leblebibioglu, DDS, MS, PhD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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