OXIDATIVE STRESS MARKERS IN GINGIVAL CREVICULAR FLUID IN PATIENTS WITH PERIODONTAL DISEASE AND HYPERLIPIDEMIA

Hyperlipidemia, Periodontitis, Gingivitis Clinical Trial

Official title:

GINGIVAL CREVICULAR FLUID MALONDIALDEHYDE, PROTEIN CARBONYL AND TOTAL ANTIOXIDANT CAPACITY IN PATIENTS WITH PERIODONTAL DISEASE AND HYPERLIPIDEMIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808130
• Other study ID #: OMU KAEK 2012/43-0.06.12
• Status: Completed
• Phase: N/A
• First received: June 17, 2016
• Last updated: June 17, 2016
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: June 2016
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: TURKEY: HUMAN ETHICS COMMITTEE OF MINISTRY OF HEALTH
• Study type: Observational

Clinical Trial Summary

we 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,

Description:

An observational study was performed in 45 hyperlipidemic(22 females, 23 males) and 45 age and sex matched normolipidemic (25 females, 20 males) healhy 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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. impared 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 meatbolism; (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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Hyperlipidemia, Periodontitis, Gingivitis
• Hyperlipidemias
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• hyperlipidemia, periodontitis, gingivitis
GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Crevicular Fluid level of malondialdehyde (MDA) as a marker of lipid oxidation.	Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipid. Malondialdehyde (MDA) is the most specific and the most often used molecule in the measurement of biological lipid oxidation	8-10 am on the day following periodontal status assessment.	Yes
Primary	Protein Carbonyl level in gingival crevicular fluid as a marker of protein oxidation	Protein carbonylation is another nonenzymatic oxidative post-translational modification and assesed by protein carbonyl tissue content that is often used as a biomarker of oxidative stress.	8-10 am on the day following periodontal status assessment.	Yes
Primary	Total Antioxidant Capacity levels in gingival crevicular fluid as a marker of antioxidant status	Contrary to oxidant mediators, TAOC provides an extensive overview of the antioxidant status of the individuals and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of TAOC can provide a more accurate and extensive assessment of antioxidant status rather than the separate measurement of individual antioxidant molecules	8-10 am on the day following periodontal status assessment.	Yes