Clinical trial NCT02808130: PERIODONTAL DISEASE AND HYPERLIPIDEMIA
Official title: A CASE CONTROL STUDY TO DETERMINE THE GINGIVAL CREVICULAR FLUID MALONDIALDEHYDE, PROTEIN CARBONYL AND TOTAL ANTIOXIDANT CAPACITY IN PATIENTS WITH PERIODONTAL DISEASE AND HYPERLIPIDEMIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia, Periodontitis, Gingivitis
Keywords: hyperlipidemia, periodontal disease, oxidative stress,
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An observational case-control study was performed in 45 hyperlipidemic(22 females, 23 males) and 45 age and sex matched normolipidemic (25 females, 20 males) healhy controls.

Brief summary: The investigators hypothesized that hyperlipidemia as an unfavourable levels of lipoprotein subfractions have deleterious impact on the development of periodontal infection by altering oxidative stres status of periodontal tissues. The aim of this study was therefore to investigate i) effect of hyperlipidemia on oxidative change in GCF content, ie. MDA, PC and TAOC levels in patients with different periodontal status,

Detailed description: An observational study was performed in 45 hyperlipidemic(22 females, 23 males) and 45 age and sex matched normolipidemic (25 females, 20 males) healthy controls. The participants were recruited as a joint collaboration between Periodontology Department of the Faculty of Dentistry and the Endocrinology and Metabolic Diseases Department of the Faculty of Medicine at Ondokuz Mayis University in Samsun, Turkey between january 2013 and august 2014.The study protocol was approved by the Local Ethics Committee, and written informed consent was obtained from all study participants in accordance with the Helsinki Declaration (revised in 2000) It has been asserted that elevated serum lipid levels create a pro-inflammatory state, which leads to an increase in oxidative state by composing an imbalanced production between highly reactive molecular species and antioxidant defences, consequently predisposing one to infections. Hyperlipidemia claimed to lead an increase in production of reactive oxygen species (ROS) and lipid peroxidation (LPO). On the other hand it has been suggested that high-cholesterol diet increases OS and causes oxidative damage in various organs. Also, OS related mediators have frequently shown to be associated with chronic periodontitis (CP) related inflammatory responses . Excessive ROS derived radical formations reported to have an important role in the inflammatory process by leading to damage to proteins, DNA, carbohydrates, and lipids.

Hyperlipidemia was defined as the presence of one or more altered values of the lipid profile and the following cut-off values were used according to the laboratory's recommendation: TC\>200mg/dl; TG\>200mg/dl; LDL cholesterol \>130 mg/dl; HDL \<35mg/dl).

Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index ; Löe \& Silness gingival index ; Probing pocket dept,clinical attachment level, bleeding on probing (BOP) measurements were performed on 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) using a Williams periodontal probe. GCF collection was subsequently performed using those sites that fit the criteria for GCF sampling described below.

All samples were collected between 8-10 am on the day following periodontal status assessment. Samples were collected from the deepest 6 sites in the chronic periodontitis group. In the gingivitis group samples were collected from the teeth with bleeding on probing, whereas teeth without BOP were chosen in the healthy group. GCF samples were collected from the similar 6 sites in the gingivitis and periodontally healthy groups in order to maintain consistency of sampling. Accordingly, total of 90 GCF samples were taken from each of the 6 groups (15 individuals per group x 6 sites).

Eligibility criteria: Inclusion Criteria:

(i) ≥ 18 years of age and having ≥ 16 teeth; (ii)no periodontal therapy in the 6 months prior to data collection; (iii) no systemic problems or chemotherapy within the 6 weeks prior to data collection and any anti-lipaemic drug treatment; (iv) no previous history of smoking.

Exclusion Criteria:

(i) medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease and any other systemic disease affecting lipid metabolism(i.e. impaired glucose tolerance, metabolic syndrome); (ii) compromised immune system; (iii) pregnancy, menopause, or lactation; (iv) ongoing drug therapy that might affect the clinical characteristics of periodontitis and lipid metabolism; (v) use of systemic antimicrobials during the 6 weeks prior to data collection; and (vi) dental treatment during the 6 months prior to data collection.

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Primary outcomes:
measure: Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.
timeFrame: 8-10 am on the day following periodontal status assessment.
measure: Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation
timeFrame: 8-10 am on the day following periodontal status assessment.
measure: Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status
timeFrame: 8-10 am on the day following periodontal status assessment.
Secondary outcomes:
Other outcomes:
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