Trial Outcomes & Findings for PERIODONTAL DISEASE AND HYPERLIPIDEMIA (NCT NCT02808130)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

90 participants

Primary outcome timeframe

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

Results posted on

2016-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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	Group HH Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic 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	Group HG Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic 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	Group HCP Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic 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
Overall Study STARTED	15	15	15	15	15	15
Overall Study COMPLETED	15	15	15	15	15	15
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PERIODONTAL DISEASE AND HYPERLIPIDEMIA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group H n=15 Participants 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	Group G n=15 Participants 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	Group CP n=15 Participants 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	Group HH n=15 Participants 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	Group HG n=15 Participants 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	Group HCP n=15 Participants 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	Total n=90 Participants Total of all reporting groups
Age, Continuous age	38.3 years STANDARD_DEVIATION 4.84 • n=99 Participants	40.04 years STANDARD_DEVIATION 3.93 • n=107 Participants	42.17 years STANDARD_DEVIATION 3.1 • n=206 Participants	45.47 years STANDARD_DEVIATION 6.66 • n=7 Participants	41 years STANDARD_DEVIATION 5.91 • n=31 Participants	41.45 years STANDARD_DEVIATION 4.81 • n=30 Participants	41.40 years STANDARD_DEVIATION 4.87 • n=3 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	8 Participants n=107 Participants	5 Participants n=206 Participants	6 Participants n=7 Participants	7 Participants n=31 Participants	6 Participants n=30 Participants	40 Participants n=3 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	7 Participants n=107 Participants	10 Participants n=206 Participants	9 Participants n=7 Participants	8 Participants n=31 Participants	9 Participants n=30 Participants	50 Participants n=3 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Group H n=15 Participants 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	Group G n=15 Participants 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	Group CP n=15 Participants 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	Group HH n=15 Participants 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	Group HG n=15 Participants 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	Group HCP n=15 Participants 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
Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.	144.09 pg/ml Standard Error 4.15	298.52 pg/ml Standard Error 18.90	802.09 pg/ml Standard Error 88.17	139.50 pg/ml Standard Error 3.40	292.98 pg/ml Standard Error 4.03	899.73 pg/ml Standard Error 16.58

PRIMARY outcome

Timeframe: 8-10 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.

Outcome measures

Outcome measures
Measure	Group H n=15 Participants 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	Group G n=15 Participants 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	Group CP n=15 Participants 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	Group HH n=15 Participants 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	Group HG n=15 Participants 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	Group HCP n=15 Participants 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
Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation	0.05 pg/ml Standard Error 0.002	0.31 pg/ml Standard Error 0.004	1.91 pg/ml Standard Error 0.081	0.07 pg/ml Standard Error 0.003	0.41 pg/ml Standard Error 0.019	2.89 pg/ml Standard Error 0.104

PRIMARY outcome

Timeframe: 8-10 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