Periodontitis Chronic Generalized SevereNCT05548933
Effects of Non-surgical Periodontal Therapy on Severe Periodontitis and Hyperlipidemia
An observational study of Periodontitis Chronic Generalized Severe and Hyperlipidemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontitis Chronic Generalized Severe, Hyperlipidemia, Gingival Crevicular Fluid
- What is being tested?
- non-surgical periodontal therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: People in Southern China
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Yanmin Wu, +86 0571 87783607, wuyanmin@zju.edu.cn
About this study
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
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.
- Conditions
- Periodontitis Chronic Generalized Severe, Hyperlipidemia, Gingival Crevicular Fluid, Serum, Biomarkers, Non-surgical Periodontal Therapy
- Being tested
- non-surgical periodontal therapy
- Keywords
- severe periodontitis, hyperlipidemia, gingival crevicular fluid, serum, biomarkers, non-surgical periodontal therapy
- Medical subject headings
- Hyperlipidemias, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal therapyProcedure or surgery
supragingival scaling,subgingival scaling
| Study group | Role | What they receive |
|---|---|---|
| HP | Chronic periodontitis (stage III/IV) patients with hyperlipidemia Receives: Procedure: non-surgical periodontal therapy | |
| CP | Chronic periodontitis(stage III/IV) patients without hyperlipidemia Receives: Procedure: non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocyte chemotactic protein-1，MCP-1
Concentration of MCP-1 in gingival crevicular fluids
Measured: Before surgery
monocyte chemotactic protein-1，MCP-1
Concentration of MCP-1 in gingival crevicular fluids
Measured: 1 month after surgery
monocyte chemotactic protein-1，MCP-1
Concentration of MCP-1 in gingival crevicular fluids
Measured: 3 months after surgery
oxidized low-density lipoprotein cholesterol, oxLDL
Concentration of oxLDL in gingival crevicular fluids and serum
Measured: Before surgery
oxidized low-density lipoprotein cholesterol, oxLDL
Concentration of oxLDL in gingival crevicular fluids and serum
Measured: 1 month after surgery
oxidized low-density lipoprotein cholesterol, oxLDL
Concentration of oxLDL in gingival crevicular fluids and serum
Measured: 3 months after surgery
Secondary outcomes (21)
interleukin-8，IL-8
Concentration of IL-8 in gingival crevicular fluids
Measured: Before surgery
interleukin-8，IL-8
Concentration of IL-8 in gingival crevicular fluids
Measured: 1 month after surgery
interleukin-8，IL-8
Concentration of IL-8 in gingival crevicular fluids
Measured: 3 months after surgery
triglycerides，TG
Concentration of TG in serum
Measured: Before surgery
triglycerides，TG
Concentration of TG in serum
Measured: 1 month after surgery
triglycerides，TG
Concentration of TG in serum
Measured: 3 months after surgery
low-density lipoprotein cholesterol，LDL-C
Concentration of LDL-C in serum
Measured: Before surgery
low-density lipoprotein cholesterol，LDL-C
Concentration of LDL-C in serum
Measured: 1 month after surgery
low-density lipoprotein cholesterol，LDL-C
Concentration of LDL-C in serum
Measured: 3 months after surgery
high-density lipoprotein cholesterol，HDL-C
Concentration of HDL-C in serum
Measured: Before surgery
high-density lipoprotein cholesterol，HDL-C
Concentration of HDL-C in serum
Measured: 1 month after surgery
high-density lipoprotein cholesterol，HDL-C
Concentration of HDL-C in serum
Measured: 3 months after surgery
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.
Measured: Before surgery
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.
Measured: 1 month after surgery
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.
Measured: 3 months after surgery
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.
Measured: Before surgery
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.
Measured: 1 month after surgery
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.
Measured: 3 months after surgery
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.
Measured: Before surgery
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.
Measured: 1 month after surgery
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.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start20 Sep 2022 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Chronic Generalized SevereStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548933
- Sponsor's protocol ID
- 2022-0567
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05548933
- Acronym / sponsor ID
- 2022-0567
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP | – | Procedure: non-surgical periodontal therapyChronic periodontitis (stage III/IV) patients with hyperlipidemia |
| CP | – | Procedure: non-surgical periodontal therapyChronic periodontitis(stage III/IV) patients without hyperlipidemia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People in Southern China
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-surgical periodontal therapysupragingival scaling,subgingival scaling | Procedure or surgery | CP, HP |
Primary outcome
monocyte chemotactic protein-1，MCP-1
Time frame: Before surgery
Concentration of MCP-1 in gingival crevicular fluids
monocyte chemotactic protein-1，MCP-1
Time frame: 1 month after surgery
Concentration of MCP-1 in gingival crevicular fluids
monocyte chemotactic protein-1，MCP-1
Time frame: 3 months after surgery
Concentration of MCP-1 in gingival crevicular fluids
oxidized low-density lipoprotein cholesterol, oxLDL
Time frame: Before surgery
Concentration of oxLDL in gingival crevicular fluids and serum
oxidized low-density lipoprotein cholesterol, oxLDL
Time frame: 1 month after surgery
Concentration of oxLDL in gingival crevicular fluids and serum
oxidized low-density lipoprotein cholesterol, oxLDL
Time frame: 3 months after surgery
Concentration of oxLDL in gingival crevicular fluids and serum
21 secondary outcomes
interleukin-8，IL-8
Time frame: Before surgery
interleukin-8，IL-8
Time frame: 1 month after surgery
interleukin-8，IL-8
Time frame: 3 months after surgery
triglycerides，TG
Time frame: Before surgery
triglycerides，TG
Time frame: 1 month after surgery
triglycerides，TG
Time frame: 3 months after surgery
low-density lipoprotein cholesterol，LDL-C
Time frame: Before surgery
low-density lipoprotein cholesterol，LDL-C
Time frame: 1 month after surgery
low-density lipoprotein cholesterol，LDL-C
Time frame: 3 months after surgery
high-density lipoprotein cholesterol，HDL-C
Time frame: Before surgery
high-density lipoprotein cholesterol，HDL-C
Time frame: 1 month after surgery
high-density lipoprotein cholesterol，HDL-C
Time frame: 3 months after surgery
probing depth，PD
Time frame: Before surgery
probing depth，PD
Time frame: 1 month after surgery
probing depth，PD
Time frame: 3 months after surgery
clinical attachment level，CAL
Time frame: Before surgery
clinical attachment level，CAL
Time frame: 1 month after surgery
clinical attachment level，CAL
Time frame: 3 months after surgery
percentage of bleeding on probing，BOP%
Time frame: Before surgery
percentage of bleeding on probing，BOP%
Time frame: 1 month after surgery
percentage of bleeding on probing，BOP%
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis Chronic Generalized Severe and Hyperlipidemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanmin Wu (+86 137 5711 9560, wuyanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monocyte chemotactic protein-1，MCP-1 (time frame: Before surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.