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

September 17, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Effects of Nonsurgical Periodontal Therapy on Biomarkers in Serum and Gingival Crevicular Fluid in Severe Periodontitis (Stage III/IV) and Hyperlipidemia:A Cohort Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People in Southern China

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
monocyte chemotactic protein-1，MCP-1
Time Frame: Before surgery
Concentration of MCP-1 in gingival crevicular fluids
Before surgery
monocyte chemotactic protein-1，MCP-1
Time Frame: 1 month after surgery
Concentration of MCP-1 in gingival crevicular fluids
1 month after surgery
monocyte chemotactic protein-1，MCP-1
Time Frame: 3 months after surgery
Concentration of MCP-1 in gingival crevicular fluids
3 months after surgery
oxidized low-density lipoprotein cholesterol, oxLDL
Time Frame: Before surgery
Concentration of oxLDL in gingival crevicular fluids and serum
Before surgery
oxidized low-density lipoprotein cholesterol, oxLDL
Time Frame: 1 month after surgery
Concentration of oxLDL in gingival crevicular fluids and serum
1 month after surgery
oxidized low-density lipoprotein cholesterol, oxLDL
Time Frame: 3 months after surgery
Concentration of oxLDL in gingival crevicular fluids and serum
3 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
interleukin-8，IL-8
Time Frame: Before surgery
Concentration of IL-8 in gingival crevicular fluids
Before surgery
interleukin-8，IL-8
Time Frame: 1 month after surgery
Concentration of IL-8 in gingival crevicular fluids
1 month after surgery
interleukin-8，IL-8
Time Frame: 3 months after surgery
Concentration of IL-8 in gingival crevicular fluids
3 months after surgery
triglycerides，TG
Time Frame: Before surgery
Concentration of TG in serum
Before surgery
triglycerides，TG
Time Frame: 1 month after surgery
Concentration of TG in serum
1 month after surgery
triglycerides，TG
Time Frame: 3 months after surgery
Concentration of TG in serum
3 months after surgery
low-density lipoprotein cholesterol，LDL-C
Time Frame: Before surgery
Concentration of LDL-C in serum
Before surgery
low-density lipoprotein cholesterol，LDL-C
Time Frame: 1 month after surgery
Concentration of LDL-C in serum
1 month after surgery
low-density lipoprotein cholesterol，LDL-C
Time Frame: 3 months after surgery
Concentration of LDL-C in serum
3 months after surgery
high-density lipoprotein cholesterol，HDL-C
Time Frame: Before surgery
Concentration of HDL-C in serum
Before surgery
high-density lipoprotein cholesterol，HDL-C
Time Frame: 1 month after surgery
Concentration of HDL-C in serum
1 month after surgery
high-density lipoprotein cholesterol，HDL-C
Time Frame: 3 months after surgery
Concentration of HDL-C in serum
3 months after surgery
probing depth，PD
Time Frame: 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.
Before surgery
probing depth，PD
Time Frame: 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.
1 month after surgery
probing depth，PD
Time Frame: 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.
3 months after surgery
clinical attachment level，CAL
Time Frame: 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.
Before surgery
clinical attachment level，CAL
Time Frame: 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.
1 month after surgery
clinical attachment level，CAL
Time Frame: 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.
3 months after surgery
percentage of bleeding on probing，BOP%
Time Frame: 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.
Before surgery
percentage of bleeding on probing，BOP%
Time Frame: 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.
1 month after surgery
percentage of bleeding on probing，BOP%
Time Frame: 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.
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-0567

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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