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Status unknownNCT05548933Updated Sep 22, 2022

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

An observational study in Periodontitis Chronic Generalized Severe, Hyperlipidemia and Gingival Crevicular Fluid, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-22.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 64 is below the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

People in Southern China

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • HP

    Chronic periodontitis (stage III/IV) patients with hyperlipidemia

    Procedure: non-surgical periodontal therapy

  • CP

    Chronic periodontitis(stage III/IV) patients without hyperlipidemia

    Procedure: non-surgical periodontal therapy

Interventions

  • Procedurenon-surgical periodontal therapy

    supragingival scaling,subgingival scaling

06

What researchers measure

Primary outcomes

  1. monocyte chemotactic protein-1,MCP-1

    Concentration of MCP-1 in gingival crevicular fluids

    Time frame: Before surgery

  2. monocyte chemotactic protein-1,MCP-1

    Concentration of MCP-1 in gingival crevicular fluids

    Time frame: 1 month after surgery

  3. monocyte chemotactic protein-1,MCP-1

    Concentration of MCP-1 in gingival crevicular fluids

    Time frame: 3 months after surgery

  4. oxidized low-density lipoprotein cholesterol, oxLDL

    Concentration of oxLDL in gingival crevicular fluids and serum

    Time frame: Before surgery

  5. oxidized low-density lipoprotein cholesterol, oxLDL

    Concentration of oxLDL in gingival crevicular fluids and serum

    Time frame: 1 month after surgery

  6. oxidized low-density lipoprotein cholesterol, oxLDL

    Concentration of oxLDL in gingival crevicular fluids and serum

    Time frame: 3 months after surgery

Secondary outcomes

  1. interleukin-8,IL-8

    Concentration of IL-8 in gingival crevicular fluids

    Time frame: Before surgery

  2. interleukin-8,IL-8

    Concentration of IL-8 in gingival crevicular fluids

    Time frame: 1 month after surgery

  3. interleukin-8,IL-8

    Concentration of IL-8 in gingival crevicular fluids

    Time frame: 3 months after surgery

  4. triglycerides,TG

    Concentration of TG in serum

    Time frame: Before surgery

  5. triglycerides,TG

    Concentration of TG in serum

    Time frame: 1 month after surgery

  6. triglycerides,TG

    Concentration of TG in serum

    Time frame: 3 months after surgery

  7. low-density lipoprotein cholesterol,LDL-C

    Concentration of LDL-C in serum

    Time frame: Before surgery

  8. low-density lipoprotein cholesterol,LDL-C

    Concentration of LDL-C in serum

    Time frame: 1 month after surgery

  9. low-density lipoprotein cholesterol,LDL-C

    Concentration of LDL-C in serum

    Time frame: 3 months after surgery

  10. high-density lipoprotein cholesterol,HDL-C

    Concentration of HDL-C in serum

    Time frame: Before surgery

  11. high-density lipoprotein cholesterol,HDL-C

    Concentration of HDL-C in serum

    Time frame: 1 month after surgery

  12. high-density lipoprotein cholesterol,HDL-C

    Concentration of HDL-C in serum

    Time frame: 3 months after surgery

  13. 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.

    Time frame: Before surgery

  14. 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.

    Time frame: 1 month after surgery

  15. 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.

    Time frame: 3 months after surgery

  16. 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.

    Time frame: Before surgery

  17. 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.

    Time frame: 1 month after surgery

  18. 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.

    Time frame: 3 months after surgery

  19. 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.

    Time frame: Before surgery

  20. 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.

    Time frame: 1 month after surgery

  21. 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.

    Time frame: 3 months after surgery

07

Study locations

1 of 1 sites recruiting
  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05548933
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Sep 22, 2022
Start date
Sep 20, 2022 (estimated)
Primary completion
Nov 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Sep 22, 2022

Study contacts

Yanmin Wu
Contact
wuyanmin@zju.edu.cn
+86 137 5711 9560

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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