Serum Inflammatory Protein Concentration During Dental Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-75
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 21-75 years of age
Systemically healthy
Non-smoker
scheduled to receive nonsurgical or surgical periodontal treatment under IV sedation
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Blood samples for inflammatory markers
Other interventionBlood samples will be obtained before the start of the procedure, the midpoint of the procedure, and the end of the procedure.
periodontal surgery
Procedure/SurgeryPeriodontal/peri-implant surgical interventions, with or without IV sedation, as based on treatment needs
Periodontal maintenance
Procedure/SurgeryRegular cleaning to maintain health after surgical treatment for periodontal disease
Non-surgical deep cleaning
Procedure/SurgeryDebridement under local anesthesia, as based on treatment needs
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Control group 12 interventions
Group B: Control group 22 interventions
Group C: Surgical group2 interventions
Trial outcomes
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 intervention3
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 procedureSponsors and contacts
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Source ClinicalTrials.gov