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PERIODONTAL DISEASE AND HYPERLIPIDEMIA

A CASE CONTROL STUDY TO DETERMINE THE GINGIVAL CREVICULAR FLUID MALONDIALDEHYDE, PROTEIN CARBONYL AND TOTAL ANTIOXIDANT CAPACITY IN PATIENTS WITH PERIODONTAL DISEASE AND HYPERLIPIDEMIA

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02808130
Enrollment
90
Registered
2016-06-21
Start date
2013-01-31
Completion date
2014-08-31
Last updated
2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Periodontitis, Gingivitis

Keywords

hyperlipidemia, periodontal disease, oxidative stress,

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).

Interventions

OTHERhyperlipidemia, 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

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.8-10 am on the day following periodontal status assessment.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
Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation8-10 am on the day following periodontal status assessment.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.
Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status8-10 am on the day following periodontal status assessment.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

Participant flow

Participants by arm

ArmCount
Group H
Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. 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
15
Group G
Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions 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
15
Group CP
Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions 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
15
Group HH
Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic 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) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. 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
15
Group HG
Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic 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) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. 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
15
Group HCP
Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic 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) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein. Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions 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
15
Total90

Baseline characteristics

CharacteristicGroup HGroup GGroup CPGroup HHGroup HGGroup HCPTotal
Age, Continuous
age
38.3 years
STANDARD_DEVIATION 4.84
40.04 years
STANDARD_DEVIATION 3.93
42.17 years
STANDARD_DEVIATION 3.1
45.47 years
STANDARD_DEVIATION 6.66
41 years
STANDARD_DEVIATION 5.91
41.45 years
STANDARD_DEVIATION 4.81
41.40 years
STANDARD_DEVIATION 4.87
Sex: Female, Male
Female
8 Participants8 Participants5 Participants6 Participants7 Participants6 Participants40 Participants
Sex: Female, Male
Male
7 Participants7 Participants10 Participants9 Participants8 Participants9 Participants50 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 150 / 150 / 150 / 150 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 150 / 150 / 150 / 150 / 15

Outcome results

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

Time frame: 8-10 am on the day following periodontal status assessment.

ArmMeasureValue (MEAN)Dispersion
Group HGingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.144.09 pg/mlStandard Error 4.15
Group GGingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.298.52 pg/mlStandard Error 18.9
Group CPGingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.802.09 pg/mlStandard Error 88.17
Group HHGingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.139.50 pg/mlStandard Error 3.4
Group HGGingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.292.98 pg/mlStandard Error 4.03
Group HCPGingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.899.73 pg/mlStandard Error 16.58
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.

Time frame: 8-10 am on the day following periodontal status assessment.

ArmMeasureValue (MEAN)Dispersion
Group HProtein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation0.05 pg/mlStandard Error 0.002
Group GProtein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation0.31 pg/mlStandard Error 0.004
Group CPProtein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation1.91 pg/mlStandard Error 0.081
Group HHProtein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation0.07 pg/mlStandard Error 0.003
Group HGProtein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation0.41 pg/mlStandard Error 0.019
Group HCPProtein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation2.89 pg/mlStandard Error 0.104
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

Time frame: 8-10 am on the day following periodontal status assessment.

ArmMeasureValue (MEAN)Dispersion
Group HTotal Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status92.21 pg/mlStandard Error 1.19
Group GTotal Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status78.32 pg/mlStandard Error 0.84
Group CPTotal Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status69.70 pg/mlStandard Error 3.37
Group HHTotal Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status90.32 pg/mlStandard Error 0.74
Group HGTotal Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status70.58 pg/mlStandard Error 3.7
Group HCPTotal Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status54.12 pg/mlStandard Error 1.06

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026