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

Recruiting

• Conditions: Hyperlipidemia; Biomarkers; Non-surgical Periodontal Therapy; Gingival Crevicular Fluid; Periodontitis Chronic Generalized Severe; Serum
• Interventions: Procedure: non-surgical periodontal therapy

• Registration Number: NCT05548933
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-17
• Last Update Submitted: 2022-09-17
• Study Start: 2022-09-20
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HP	non-surgical periodontal therapy	Chronic periodontitis (stage III/IV) patients with hyperlipidemia
CP	non-surgical periodontal therapy	Chronic periodontitis(stage III/IV) patients without hyperlipidemia

Primary Outcome Measures

Name	Time	Method
oxidized low-density lipoprotein cholesterol, oxLDL	3 months after surgery	Concentration of oxLDL in gingival crevicular fluids and serum
monocyte chemotactic protein-1，MCP-1	3 months after surgery	Concentration of MCP-1 in gingival crevicular fluids

Secondary Outcome Measures

Name	Time	Method
interleukin-8，IL-8	3 months after surgery	Concentration of IL-8 in gingival crevicular fluids
high-density lipoprotein cholesterol，HDL-C	3 months after surgery	Concentration of HDL-C in serum
triglycerides，TG	3 months after surgery	Concentration of TG in serum
probing depth，PD	3 months after surgery	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.
low-density lipoprotein cholesterol，LDL-C	3 months after surgery	Concentration of LDL-C in serum
clinical attachment level，CAL	3 months after surgery	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.
percentage of bleeding on probing，BOP%	3 months after surgery	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.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China