NCT05548933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

September 13, 2022

Last Update Submit

September 17, 2022

Conditions

Periodontitis Chronic Generalized SevereHyperlipidemiaGingival Crevicular FluidSerumBiomarkersNon-surgical Periodontal Therapy

Keywords

severe periodontitishyperlipidemiagingival crevicular fluidserumbiomarkersnon-surgical periodontal therapy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (21)

  • interleukin-8，IL-8

    Before surgery

  • interleukin-8，IL-8

    1 month after surgery

  • interleukin-8，IL-8

    3 months after surgery

  • triglycerides，TG

    Before surgery

  • triglycerides，TG

    1 month after surgery

  • +16 more secondary outcomes

Study Arms (2)

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

non-surgical periodontal therapyPROCEDURE

supragingival scaling,subgingival scaling

CPHP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People in Southern China

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

HyperlipidemiasPeriodontitis

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Yanmin Wu

CONTACT

+86 137 5711 9560wuyanmin@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 22, 2022

Study Start

September 20, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

CN(1)