Hyperlipidemia, Periodontal DiseaseNCT02826720
Is There a Relationship Between Hyperlipidemia and Periodontitis?
An observational study of Hyperlipidemia, Periodontal Disease, run by Marmara University.
Trial summary
The aim of present study is to investigate any relationship between hyperlipidemia and periodontal disease regarding the periodontal parameters and plasma lipid parameters, along with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol consumption. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Hyperlipidemia, Periodontal Disease
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2016
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 240 subjects were examined among patients who attended to the Department of Periodontology, Marmara University or the Turkish Heart Foundation and had their plasma lipid values determined within the last 3 months. Out of 240, 160 subjects (57 male, 103 female, age range 35-65 years) eligible for this study were selected.
Who may be able to join
- Subjects having no periodontal treatment within previous 6 months,
- number of natural teeth ≥ 10,
- no history of cancer and systemic disease that affects lipid levels or periodontium,
- no history of medical treatment for hyperlipidemia, BMI< 30 kg/m2,
- no pregnancy,
- no history of systemic antibiotic treatment within previous 3 months,
- no smoking.
Who cannot join
- patients with history of systemic disease that affects lipid metabolism or periodontal disease
- history of medical treatment for hyperlipidemia
- pregnancy, lactation or hormone replacement therapy at the time of study
- use of any other drug known to affect lipid metabolism or periodontal disease
- systemic infection or any history of systemic antibiotic treatment in previous 3 months
- smokers as well as ex-smokers
About this study
The aim of present study is to investigate any relationship between hyperlipidemia and periodontal disease regarding the periodontal parameters and plasma lipid parameters, along with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol consumption.
In this cross sectional study, a total of 160 individuals were divided into two groups based on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63). Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL) clinical parameters and community periodontal index of treatment needs (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had been determined previously during individuals routine systemic examinations. Daily brushing habits and interdental cleaning together with dietary habits, alcohol consumption and physical activity levels were also recorded.
- Conditions
- Hyperlipidemia, Periodontal Disease
- Being tested
- No intervention was applied
- Keywords
- HDL cholesterol, Hyperlipidemia, LDL cholesterol, Periodontal disease, Triglyceride
- Medical subject headings
- Hyperlipidemias, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was appliedOther
No intervention was applied
| Study group | Role | What they receive |
|---|---|---|
| HP+ | Subjects with plasma Triglyceride or Total cholesterol levels > 200 mg/dl and low density lipoprotein-cholesterol levels > 130 mg/dl were included in the hyperlipidemic group and having periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. Receives: Other: No intervention was applied | |
| HP- | Subjects with plasma Triglyceride or Total cholesterol levels > 200 mg/dl and low density lipoprotein-cholesterol levels > 130 mg/dl were included in the hyperlipidemic group and do not have periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. Receives: Other: No intervention was applied | |
| NP+ | Subjects with plasma Triglyceride or Total cholesterol levels < 200 mg/dl and low density lipoprotein-cholesterol levels < 130 mg/dl were included in the normolipidemic group and having periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. Receives: Other: No intervention was applied | |
| NP- | Subjects with plasma Triglyceride or Total cholesterol levels < 200 mg/dl and low density lipoprotein-cholesterol levels < 130 mg/dl were included in the normolipidemic group and do not have periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. Receives: Other: No intervention was applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride (TG)
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
Measured: day 0
Total cholesterol (TC)
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
Measured: day 0
Low density lipoprotein cholesterol (LDL-C)
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
Measured: day 0
Secondary outcomes (6)
Plaque index
The measurement of the state of oral hygiene based on recording dental plaque accumulation
Measured: day 0
Gingival index
An assessment level of gingival health and inflammation
Measured: day 0
Bleeding on probing
A sign of gingival inflammation were assessed on the buccal, lingual, mesial and distal sites of each tooth
Measured: day 0
Probing depth
The distance from the gingival margin to bottom of the pocket with using 0.5 mm diameter periodontal probe at mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual sites of each tooth
Measured: day 0
Clinical attachment level
The distance between the cemento-enamel junction and bottom of the pocket
Measured: day 0
Community Periodontal Index of Treatment Needs score
These scores are used to represent healthy periodontium, bleeding after probing, dental calculus detected by probing, 4-5 mm deep pockets and deep pockets ≥ 6 mm, respectively.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipidemia, Periodontal DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gülin Tulu Katı, PhD, Principal investigator, Periodontist in Private Practice., Istanbul, Turkey. (E-mail: gulintulu@gmail.com)Ülkü Noyan, Prof. Dr., Study chair, Periodontist in Private Practice., Istanbul, Turkey. (E-mail: noyanulku@yahoo.com)Bahar Kuru, Prof. Dr., Study chair, Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey. (E-mail: baharkuru@gmail.com)Leyla Kuru, Prof. Dr., Study director, Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (E-mail: lkuru@marmara.edu.tr)Ömer Birkan Ağralı, PhD, Study chair, Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (omer.agrali@marmara.edu.tr)Hatice Selin Yıldırım, PhD, Study chair, Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey. (Email: yildirimselin@hotmail.com)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826720
- Sponsor's protocol ID
- MIHS-25
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Relationship Between Hyperlipidemia and Periodontitis?
- ClinicalTrials.gov ID
- NCT02826720
- Acronym / sponsor ID
- MIHS-25
- Conditions
- Hyperlipidemia, Periodontal Disease
- Keywords
- HDL cholesterol, Hyperlipidemia, LDL cholesterol, Periodontal disease, Triglyceride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The aim of present study is to investigate any relationship between hyperlipidemia and periodontal disease regarding the periodontal parameters and plasma lipid parameters, along with age, gender, brushing habit, body mass index, dietary habit, physical activity, alcohol consumption.
In this cross sectional study, a total of 160 individuals were divided into two groups based on their metabolic status: hyperlipidemic group (n=97) and normolipidemic group (n=63). Plaque index, gingival index, bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL) clinical parameters and community periodontal index of treatment needs (CPITN) scores were measured. Triglyceride (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C) levels had been determined previously during individuals routine systemic examinations. Daily brushing habits and interdental cleaning together with dietary habits, alcohol consumption and physical activity levels were also recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HP+ | – | Other: No intervention was appliedSubjects with plasma Triglyceride or Total cholesterol levels > 200 mg/dl and low density lipoprotein-cholesterol levels > 130 mg/dl were included in the hyperlipidemic group and having periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. |
| HP- | – | Other: No intervention was appliedSubjects with plasma Triglyceride or Total cholesterol levels > 200 mg/dl and low density lipoprotein-cholesterol levels > 130 mg/dl were included in the hyperlipidemic group and do not have periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. |
| NP+ | – | Other: No intervention was appliedSubjects with plasma Triglyceride or Total cholesterol levels < 200 mg/dl and low density lipoprotein-cholesterol levels < 130 mg/dl were included in the normolipidemic group and having periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. |
| NP- | – | Other: No intervention was appliedSubjects with plasma Triglyceride or Total cholesterol levels < 200 mg/dl and low density lipoprotein-cholesterol levels < 130 mg/dl were included in the normolipidemic group and do not have periodontitis which were further evaluated for clinical periodontal parameters as well as to define the effects of the patient's habits on plasma lipid levels. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 240 subjects were examined among patients who attended to the Department of Periodontology, Marmara University or the Turkish Heart Foundation and had their plasma lipid values determined within the last 3 months. Out of 240, 160 subjects (57 male, 103 female, age range 35-65 years) eligible for this study were selected.
Key inclusion criteria (7 listed)
- Subjects having no periodontal treatment within previous 6 months,
- number of natural teeth ≥ 10,
- no history of cancer and systemic disease that affects lipid levels or periodontium,
- no history of medical treatment for hyperlipidemia, BMI< 30 kg/m2,
- no pregnancy,
Key exclusion criteria (6 listed)
- patients with history of systemic disease that affects lipid metabolism or periodontal disease
- history of medical treatment for hyperlipidemia
- pregnancy, lactation or hormone replacement therapy at the time of study
- use of any other drug known to affect lipid metabolism or periodontal disease
- systemic infection or any history of systemic antibiotic treatment in previous 3 months
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 |
|---|---|---|
| No intervention was appliedNo intervention was applied | Other | HP+, HP-, NP+, NP- |
Primary outcome
Triglyceride (TG)
Time frame: day 0
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
Total cholesterol (TC)
Time frame: day 0
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
Low density lipoprotein cholesterol (LDL-C)
Time frame: day 0
Subjects with plasma TG or TC levels > 200 mg/dl and LDL-C levels > 130 mg/dl were included in the hyperlipidemic group, while the normolipidemic group comprised of patients with plasma TG or TC levels below the aforementioned limits
6 secondary outcomes
Plaque index
Time frame: day 0
Gingival index
Time frame: day 0
Bleeding on probing
Time frame: day 0
Probing depth
Time frame: day 0
Clinical attachment level
Time frame: day 0
Community Periodontal Index of Treatment Needs score
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
Related trials for Hyperlipidemia, Periodontal Disease
Not yet recruitingObservational study
Gingival Crevicular Fluid Oxidized Low-Density Lipoprotein Levels in Health and Stage III/IV Periodontitis
Periodontal Diseases, LDL Hyperlipoproteinemia
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.
Gülin Tulu Katı, PhD principal investigator
Periodontist in Private Practice., Istanbul, Turkey. (E-mail: gulintulu@gmail.com)
Ülkü Noyan, Prof. Dr. study chair
Periodontist in Private Practice., Istanbul, Turkey. (E-mail: noyanulku@yahoo.com)
Bahar Kuru, Prof. Dr. study chair
Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey. (E-mail: baharkuru@gmail.com)
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, Periodontal Disease, run by Marmara University.
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 7 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: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride (TG) (time frame: day 0). The study lists 3 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 11 Jul 2016.