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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Biomarkers; Hyperlipidemia; Serum; Periodontitis Chronic Generalized Severe; Gingival Crevicular Fluid; Non-surgical Periodontal Therapy
• Intervention / Treatment: Procedure: non-surgical periodontal therapy

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 64

Contacts and Locations

• Study Contact: Name: Yanmin Wu; Phone Number: +86 137 5711 9560; Email: wuyanmin@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People in Southern China

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HP; Chronic periodontitis (stage III/IV) patients with hyperlipidemia	Procedure: non-surgical periodontal therapy; supragingival scaling,subgingival scaling
CP; Chronic periodontitis(stage III/IV) patients without hyperlipidemia	Procedure: non-surgical periodontal therapy; supragingival scaling,subgingival scaling

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 17, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: biomarkers; hyperlipidemia; serum; gingival crevicular fluid; non-surgical periodontal therapy; severe periodontitis
• Additional Relevant MeSH Terms: Metabolic Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Lipid Metabolism Disorders; Dyslipidemias; Periodontitis; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 2022-0567

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No