Hyperlipidemia, Periodontal Disease Clinical Trial
Official title:
Is There a Relationship Between Hyperlipidemia and Periodontitis?
| Verified date | July 2016 |
| Source | Marmara University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | March 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Marmara University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | day 0 | Yes |
| Primary | 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 | day 0 | Yes |
| Primary | 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 | day 0 | Yes |
| Secondary | Plaque index | The measurement of the state of oral hygiene based on recording dental plaque accumulation | day 0 | Yes |
| Secondary | Gingival index | An assessment level of gingival health and inflammation | day 0 | Yes |
| Secondary | Bleeding on probing | A sign of gingival inflammation were assessed on the buccal, lingual, mesial and distal sites of each tooth | day 0 | Yes |
| Secondary | 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 | day 0 | Yes |
| Secondary | Clinical attachment level | The distance between the cemento-enamel junction and bottom of the pocket | day 0 | Yes |
| Secondary | 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. | day 0 | Yes |