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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05548933
Collaborator
(none)
64
1
13.4
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
64 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Sep 20, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. monocyte chemotactic protein-1,MCP-1 [Before surgery]

    Concentration of MCP-1 in gingival crevicular fluids

  2. monocyte chemotactic protein-1,MCP-1 [1 month after surgery]

    Concentration of MCP-1 in gingival crevicular fluids

  3. monocyte chemotactic protein-1,MCP-1 [3 months after surgery]

    Concentration of MCP-1 in gingival crevicular fluids

  4. oxidized low-density lipoprotein cholesterol, oxLDL [Before surgery]

    Concentration of oxLDL in gingival crevicular fluids and serum

  5. oxidized low-density lipoprotein cholesterol, oxLDL [1 month after surgery]

    Concentration of oxLDL in gingival crevicular fluids and serum

  6. oxidized low-density lipoprotein cholesterol, oxLDL [3 months after surgery]

    Concentration of oxLDL in gingival crevicular fluids and serum

Secondary Outcome Measures

  1. interleukin-8,IL-8 [Before surgery]

    Concentration of IL-8 in gingival crevicular fluids

  2. interleukin-8,IL-8 [1 month after surgery]

    Concentration of IL-8 in gingival crevicular fluids

  3. interleukin-8,IL-8 [3 months after surgery]

    Concentration of IL-8 in gingival crevicular fluids

  4. triglycerides,TG [Before surgery]

    Concentration of TG in serum

  5. triglycerides,TG [1 month after surgery]

    Concentration of TG in serum

  6. triglycerides,TG [3 months after surgery]

    Concentration of TG in serum

  7. low-density lipoprotein cholesterol,LDL-C [Before surgery]

    Concentration of LDL-C in serum

  8. low-density lipoprotein cholesterol,LDL-C [1 month after surgery]

    Concentration of LDL-C in serum

  9. low-density lipoprotein cholesterol,LDL-C [3 months after surgery]

    Concentration of LDL-C in serum

  10. high-density lipoprotein cholesterol,HDL-C [Before surgery]

    Concentration of HDL-C in serum

  11. high-density lipoprotein cholesterol,HDL-C [1 month after surgery]

    Concentration of HDL-C in serum

  12. high-density lipoprotein cholesterol,HDL-C [3 months after surgery]

    Concentration of HDL-C in serum

  13. probing depth,PD [Before 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.

  14. probing depth,PD [1 month 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.

  15. 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.

  16. clinical attachment level,CAL [Before 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.

  17. clinical attachment level,CAL [1 month 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.

  18. 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.

  19. percentage of bleeding on probing,BOP% [Before 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.

  20. percentage of bleeding on probing,BOP% [1 month 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.

  21. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05548933
Other Study ID Numbers:
  • 2022-0567
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2022