- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526883
The Effect of Non-Surgical Periodontal Treatment on Systemic Inflammatory Markers and Lipid Profile in Young Adults With Severe Periodontitis
The goal of this clinical study was to evaluate whether non-surgical treatment for severe periodontitis (gum disease) could improve body-wide inflammation and blood fat levels in young adults with severe periodontitis. The main questions it aimed to answer were:
Did non-surgical periodontal treatment improve gum health in young adults with severe periodontitis?
Did non-surgical periodontal treatment change body-wide inflammation and blood fat levels after treatment?
Researchers compared participants with severe periodontitis to healthy participants without periodontitis.
Participants with severe periodontitis:
- Received oral hygiene instructions, deep cleaning below the gumline, root surface cleaning, and removal of teeth that could not be saved
- Had full-mouth gum examinations
- Provided blood samples at the start of the study and again at 2 and 6 months after treatment
Healthy participants:
- Had gum examinations
- Provided blood samples for comparison at the start of the study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Istanbul University, Faculty of Dentistry, Department of Periodontology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Young adults aged 19 to 36 years
- At least 20 teeth present
- Clinical attachment loss of at least 5 mm affecting at least 8 teeth
- Bone loss around at least 3 teeth other than incisors and first molars
Exclusion Criteria:
- Systemic disease
- Pregnancy or lactation
- Current or former smoking
- Systemic conditions that could alter the host response
- Medical conditions requiring antibiotic prophylaxis during routine dental procedures
- Antibiotic therapy within the previous 6 months
- Previous periodontal treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Healthy Group
The healthy control arm included systemically and periodontally healthy young adults with no periodontal or systemic disease who met the same exclusion criteria as the periodontitis group.
Participants did not receive periodontal treatment.
They underwent baseline full-mouth periodontal examination and blood sampling to provide healthy reference values.
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Active Comparator: Periodontitis Group
The periodontitis arm included systemically healthy young adults with severe periodontitis.
Participants underwent baseline full-mouth periodontal examination and blood sampling, received non-surgical periodontal treatment, and were re-evaluated at 2 and 6 months after treatment.
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Non-surgical periodontal treatment consisted of oral hygiene instruction, subgingival scaling, root planing, and extraction of unsalvageable teeth under local anesthesia.
Treatment was completed within 1 week.
Clinical periodontal measurements and blood samples were obtained at baseline and repeated at 2 and 6 months after completion of treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change in serum high-sensitivity C-reactive protein (hs-CRP) concentration after periodontal treatment
Time Frame: 6 months
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This change is measured in serum, as mg/dl, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
The study was powered on the change in this parameter from baseline to 6 months after treatment.
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6 months
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The change in HDL cholesterol concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in LDL cholesterol concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in total cholesterol concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in triglyceride concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in albumin concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in von Willebrand factor (vWf) level after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in creatinine concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in fibrinogen concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as mg/dL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in Factor VII level after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in interleukin-1 receptor (IL-1ra) antagonist concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in interleukin-6 (IL-6) level after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in soluble tumor necrosis factor receptor I (sTNFRI) concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in soluble tumor necrosis factor receptor II concentration (sTNFRII) after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as pg/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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The change in tissue plasminogen activator (tPA) concentration after periodontal treatment
Time Frame: 6 months
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This parameter is measured in blood samples, as ng/mL, recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the systemic biomarker panel examined to characterize the systemic inflammatory and metabolic profile of the study participants.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change in sulcus bleeding index (SBI) after periodontal treatment
Time Frame: 6 months
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This parameter is measured by clinical examination, as a percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the clinical periodontal parameters recorded to characterize the periodontal status of the study participants.
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6 months
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The change in plaque index (PI) after periodontal treatment
Time Frame: 6 months
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This parameter is measured by clinical examination, as a percentage (%), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the clinical periodontal parameters recorded to characterize the periodontal status of the study participants.
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6 months
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The change in clinical attachment level (CAL) after periodontal treatment
Time Frame: 6 months
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This parameter is measured by clinical examination, in millimeters (mm), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the clinical periodontal parameters recorded to characterize the periodontal status of the study participants.
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6 months
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The change in probing pocket depth (PPD) after periodontal treatment
Time Frame: 6 months
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This parameter is measured by clinical examination, in millimeters (mm), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the clinical periodontal parameters recorded to characterize the periodontal status of the study participants.
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6 months
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The change in level of gingival margin (LGM) after periodontal treatment
Time Frame: 6 months
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This parameter is measured by clinical examination, in millimeters (mm), recorded at baseline, 2 and 6 months after non-surgical periodontal treatment.
It is part of the clinical periodontal parameters recorded to characterize the periodontal status of the study participants.
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006/1469
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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