Clinical trial NCT05548933: Effects of Non-surgical Periodontal Therapy on Severe Periodontitis and Hyperlipidemia
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis Chronic Generalized Severe
Hyperlipidemia
Gingival Crevicular Fluid
Serum
Biomarkers
Non-surgical Periodontal Therapy
Keywords: severe periodontitis
hyperlipidemia
gingival crevicular fluid
serum
biomarkers
non-surgical periodontal therapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People in Southern China

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.

Eligibility criteria: 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

Primary outcomes:
measure: monocyte chemotactic protein-1，MCP-1
timeFrame: Before surgery
measure: monocyte chemotactic protein-1，MCP-1
timeFrame: 1 month after surgery
measure: monocyte chemotactic protein-1，MCP-1
timeFrame: 3 months after surgery
measure: oxidized low-density lipoprotein cholesterol, oxLDL
timeFrame: Before surgery
measure: oxidized low-density lipoprotein cholesterol, oxLDL
timeFrame: 1 month after surgery
measure: oxidized low-density lipoprotein cholesterol, oxLDL
timeFrame: 3 months after surgery
Secondary outcomes:
measure: interleukin-8，IL-8
timeFrame: Before surgery
measure: interleukin-8，IL-8
timeFrame: 1 month after surgery
measure: interleukin-8，IL-8
timeFrame: 3 months after surgery
measure: triglycerides，TG
timeFrame: Before surgery
measure: triglycerides，TG
timeFrame: 1 month after surgery
measure: triglycerides，TG
timeFrame: 3 months after surgery
measure: low-density lipoprotein cholesterol，LDL-C
timeFrame: Before surgery
measure: low-density lipoprotein cholesterol，LDL-C
timeFrame: 1 month after surgery
measure: low-density lipoprotein cholesterol，LDL-C
timeFrame: 3 months after surgery
measure: high-density lipoprotein cholesterol，HDL-C
timeFrame: Before surgery
measure: high-density lipoprotein cholesterol，HDL-C
timeFrame: 1 month after surgery
measure: high-density lipoprotein cholesterol，HDL-C
timeFrame: 3 months after surgery
measure: probing depth，PD
timeFrame: Before surgery
measure: probing depth，PD
timeFrame: 1 month after surgery
measure: probing depth，PD
timeFrame: 3 months after surgery
measure: clinical attachment level，CAL
timeFrame: Before surgery
measure: clinical attachment level，CAL
timeFrame: 1 month after surgery
measure: clinical attachment level，CAL
timeFrame: 3 months after surgery
measure: percentage of bleeding on probing，BOP%
timeFrame: Before surgery
measure: percentage of bleeding on probing，BOP%
timeFrame: 1 month after surgery
measure: percentage of bleeding on probing，BOP%
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: