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
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:
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 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.
Exclusion Criteria:
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
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
Recruited from patients who are treatment planned for periodontal/peri-implant surgical interventions.
Other: Blood samples for inflammatory markers · Procedure: periodontal surgery
Blood samples will be obtained before the start of the procedure, the midpoint of the procedure, and the end of the procedure.
Periodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs
Regular cleaning to maintain health after surgical treatment for periodontal disease
Debridement under local anesthesia, as based on treatment needs
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;
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
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.
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;
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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ohio State University