Effects of Non-surgical Periodontal Therapy on Severe Periodontitis and Hyperlipidemia

Study Overview
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Brief Summary
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This study was a single-center, non-randomized, parallel-group design clinical trial, and each group was assigned a 1:1 ratio with or without hyperlipidemia. Both groups underwent periodontal non-surgical treatment, and blood and gingival crevicular fluid were collected before surgery, 1 month and 3 months after surgery for the detection of MCP-1, IL-8, oxLDL, TNF-α, TG, LDL-C, HDL-C.

Detailed Description
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This study was a single-center, non-randomized, parallel-group design clinical trial, and each group was assigned a 1:1 ratio with or without hyperlipidemia. Both groups underwent periodontal non-surgical treatment, and blood and gingival crevicular fluid were collected before surgery, 1 month and 3 months after surgery for the detection of MCP-1, IL-8, oxLDL, TNF-α, TG, LDL-C, HDL-C.MCP-1, IL-8, oxLDL, TNF-α will be tested for concentration using ELISA.

Official Title
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Effects of Nonsurgical Periodontal Therapy on Biomarkers in Serum and Gingival Crevicular Fluid in Severe Periodontitis (Stage III/IV) and Hyperlipidemia:A Cohort Study

Conditions
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Periodontitis Chronic Generalized Severe, Hyperlipidemia, Gingival Crevicular Fluid, Serum, Biomarkers, Non-surgical Periodontal Therapy

Intervention / Treatment
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* Procedure: non-surgical periodontal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects had to meet at least one of the following criteria for the diagnosis of hyperlipidemia: triglyceride (TRG) levels >2.26 mmol/L; high density lipoprotein cholesterol (HDL-C) levels <1.04 mmol/L; or low density lipoprotein cholesterol (LDL-C) levels >4.14 mmol/L Patients with severe periodontitis (stage III/IV) with probing depth (PD) ≥ 6 mm at at least six sites, at least two multi-rooted or two single-rooted teeth in at least one quadrant, and extended bone loss on imaging to the middle or top third of the root. Periodontitis results in the loss of less than or equal to four teeth. Exclusion Criteria: systemic illnesses pregnancy or lactation systemic antibiotics taken within the previous 6 months use of cholesterol reduction medication during the past 6 months subgingival scaling and root planing or surgical periodontal therapy in the last year chewing smokeless tobacco, smoking pipes or cigars 1 or more times per week, or smoking more than 20 cigarettes per week (1 pack per week) in the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HP<br>Chronic periodontitis (stage III/IV) patients with hyperlipidemia | Procedure: non-surgical periodontal therapy<br>* supragingival scaling,subgingival scaling<br>|
| CP<br>Chronic periodontitis(stage III/IV) patients without hyperlipidemia | Procedure: non-surgical periodontal therapy<br>* supragingival scaling,subgingival scaling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monocyte chemotactic protein-1，MCP-1 | Concentration of MCP-1 in gingival crevicular fluids | Before surgery | 
| monocyte chemotactic protein-1，MCP-1 | Concentration of MCP-1 in gingival crevicular fluids | 1 month after surgery | 
| monocyte chemotactic protein-1，MCP-1 | Concentration of MCP-1 in gingival crevicular fluids | 3 months after surgery | 
| oxidized low-density lipoprotein cholesterol, oxLDL | Concentration of oxLDL in gingival crevicular fluids and serum | Before surgery | 
| oxidized low-density lipoprotein cholesterol, oxLDL | Concentration of oxLDL in gingival crevicular fluids and serum | 1 month after surgery | 
| oxidized low-density lipoprotein cholesterol, oxLDL | Concentration of oxLDL in gingival crevicular fluids and serum | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interleukin-8，IL-8 | Concentration of IL-8 in gingival crevicular fluids | Before surgery | 
| interleukin-8，IL-8 | Concentration of IL-8 in gingival crevicular fluids | 1 month after surgery | 
| interleukin-8，IL-8 | Concentration of IL-8 in gingival crevicular fluids | 3 months after surgery | 
| triglycerides，TG | Concentration of TG in serum | Before surgery | 
| triglycerides，TG | Concentration of TG in serum | 1 month after surgery | 
| triglycerides，TG | Concentration of TG in serum | 3 months after surgery | 
| low-density lipoprotein cholesterol，LDL-C | Concentration of LDL-C in serum | Before surgery | 
| low-density lipoprotein cholesterol，LDL-C | Concentration of LDL-C in serum | 1 month after surgery | 
| low-density lipoprotein cholesterol，LDL-C | Concentration of LDL-C in serum | 3 months after surgery | 
| high-density lipoprotein cholesterol，HDL-C | Concentration of HDL-C in serum | Before surgery | 
| high-density lipoprotein cholesterol，HDL-C | Concentration of HDL-C in serum | 1 month after surgery | 
| high-density lipoprotein cholesterol，HDL-C | Concentration of HDL-C in serum | 3 months after surgery | 
| probing depth，PD | The distance (mm) from the bottom of the periodontal pocket to the gingival margin was measured with a periodontal probe (UNC-15, Hu-Friedy, Chicago, IL) parallel to the long axis of the tooth. The mesial, median and distal 6 sites of the labial (buccal) and lingual surfaces were recorded for each tooth. | Before surgery | 
| probing depth，PD | The distance (mm) from the bottom of the periodontal pocket to the gingival margin was measured with a periodontal probe (UNC-15, Hu-Friedy, Chicago, IL) parallel to the long axis of the tooth. The mesial, median and distal 6 sites of the labial (buccal) and lingual surfaces were recorded for each tooth. | 1 month after surgery | 
| probing depth，PD | The distance (mm) from the bottom of the periodontal pocket to the gingival margin was measured with a periodontal probe (UNC-15, Hu-Friedy, Chicago, IL) parallel to the long axis of the tooth. The mesial, median and distal 6 sites of the labial (buccal) and lingual surfaces were recorded for each tooth. | 3 months after surgery | 
| clinical attachment level，CAL | The periodontal probe measures the distance (mm) from the bottom of the gingival sulcus or the bottom of the periodontal pocket to the cementoenamel boundary. The mesial, median and distal 6 points of the labial (buccal) and lingual surfaces were recorded for each tooth. | Before surgery | 
| clinical attachment level，CAL | The periodontal probe measures the distance (mm) from the bottom of the gingival sulcus or the bottom of the periodontal pocket to the cementoenamel boundary. The mesial, median and distal 6 points of the labial (buccal) and lingual surfaces were recorded for each tooth. | 1 month after surgery | 
| clinical attachment level，CAL | The periodontal probe measures the distance (mm) from the bottom of the gingival sulcus or the bottom of the periodontal pocket to the cementoenamel boundary. The mesial, median and distal 6 points of the labial (buccal) and lingual surfaces were recorded for each tooth. | 3 months after surgery | 
| percentage of bleeding on probing，BOP% | Gently probe to the bottom of the bag or gingival sulcus, take out the probe and observe for 10-15 seconds to see if there is any bleeding. The mesial, median and distal 6 sites of the labial (buccal) and lingual surfaces were recorded for each tooth. Calculate the percentage of bleeding sites. | Before surgery | 
| percentage of bleeding on probing，BOP% | Gently probe to the bottom of the bag or gingival sulcus, take out the probe and observe for 10-15 seconds to see if there is any bleeding. The mesial, median and distal 6 sites of the labial (buccal) and lingual surfaces were recorded for each tooth. Calculate the percentage of bleeding sites. | 1 month after surgery | 
| percentage of bleeding on probing，BOP% | Gently probe to the bottom of the bag or gingival sulcus, take out the probe and observe for 10-15 seconds to see if there is any bleeding. The mesial, median and distal 6 sites of the labial (buccal) and lingual surfaces were recorded for each tooth. Calculate the percentage of bleeding sites. | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe periodontitis, hyperlipidemia, gingival crevicular fluid, serum, biomarkers, non-surgical periodontal therapy