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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548933
• Other study ID #: 2022-0567
• Status: Recruiting
• Start date: September 20, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: September 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yanmin Wu
• Phone: +86 137 5711 9560
• Email: wuyanmin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Gingival Crevicular Fluid
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Periodontitis
• Periodontitis Chronic Generalized Severe
• Serum

Intervention

Procedure:
• non-surgical periodontal therapy
supragingival scaling,subgingival scaling

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	monocyte chemotactic protein-1,MCP-1	Concentration of MCP-1 in gingival crevicular fluids	Before surgery
Primary	monocyte chemotactic protein-1,MCP-1	Concentration of MCP-1 in gingival crevicular fluids	1 month after surgery
Primary	monocyte chemotactic protein-1,MCP-1	Concentration of MCP-1 in gingival crevicular fluids	3 months after surgery
Primary	oxidized low-density lipoprotein cholesterol, oxLDL	Concentration of oxLDL in gingival crevicular fluids and serum	Before surgery
Primary	oxidized low-density lipoprotein cholesterol, oxLDL	Concentration of oxLDL in gingival crevicular fluids and serum	1 month after surgery
Primary	oxidized low-density lipoprotein cholesterol, oxLDL	Concentration of oxLDL in gingival crevicular fluids and serum	3 months after surgery
Secondary	interleukin-8,IL-8	Concentration of IL-8 in gingival crevicular fluids	Before surgery
Secondary	interleukin-8,IL-8	Concentration of IL-8 in gingival crevicular fluids	1 month after surgery
Secondary	interleukin-8,IL-8	Concentration of IL-8 in gingival crevicular fluids	3 months after surgery
Secondary	triglycerides,TG	Concentration of TG in serum	Before surgery
Secondary	triglycerides,TG	Concentration of TG in serum	1 month after surgery
Secondary	triglycerides,TG	Concentration of TG in serum	3 months after surgery
Secondary	low-density lipoprotein cholesterol,LDL-C	Concentration of LDL-C in serum	Before surgery
Secondary	low-density lipoprotein cholesterol,LDL-C	Concentration of LDL-C in serum	1 month after surgery
Secondary	low-density lipoprotein cholesterol,LDL-C	Concentration of LDL-C in serum	3 months after surgery
Secondary	high-density lipoprotein cholesterol,HDL-C	Concentration of HDL-C in serum	Before surgery
Secondary	high-density lipoprotein cholesterol,HDL-C	Concentration of HDL-C in serum	1 month after surgery
Secondary	high-density lipoprotein cholesterol,HDL-C	Concentration of HDL-C in serum	3 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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