Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785235
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2021-02-09
Brief Title:
Neutrophil Elastase Elastase Alpha-1 Proteinase Periodontitis Gingival Crevicular Fluid and Acute Coronary Syndrome
Sponsor:
Baskent University
Organization:
Baskent University
Study Overview
Official Title:
The Effects of Non-Surgical Periodontal Therapy on Neutrophil Elastase and Elastase Alpha-1 Proteinase Inhibitor Levels in GCF in Periodontitis Patients With or Without Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Periodontitis may contribute to vascular damage resulting in the destabilization of atherosclerotic plaque leading to acute coronary syndrome ACS In this study we explored the effect of non-surgical periodontal treatment NSPT on cardiovascular blood biomarkers and gingival crevicular fluid GCF Neutrophil Elastase NE and α1-proteinase inhibitor alpha-1PI levels in periodontitis P participants with and without ACS
Medical and dental examinations were performed to diagnose ACS and periodontitis respectively Seventeen patients with diagnosis ACS and periodontitis were included in this study as a test group Group ACS Twenty-six age and sex-matched control patients with periodontitis Group P were otherwise systemically healthy Both groups received NSPT Plasma levels of cholesterol triglyceride high-density lipoprotein HDL low-density lipoprotein LDL C-reactive protein CRP GCF NE activity and GCF α1-PI levels were measured baseline at1st and 3rd months after NSPT
Medical and dental examinations were performed to diagnose ACS and periodontitis respectively Seventeen patients with diagnosis ACS and periodontitis were included in this study as a test group Group ACS Twenty-six age and sex-matched control patients with periodontitis Group P were otherwise systemically healthy Both groups received NSPT Plasma levels of cholesterol triglyceride high-density lipoprotein HDL low-density lipoprotein LDL C-reactive protein CRP GCF NE activity and GCF α1-PI levels were measured baseline at1st and 3rd months after NSPT
Detailed Description:
This research was approved by the human participants ethics board of Selcuk University Faculty of Dentistry project number301 and was conducted in accordance with the Helsinki Declaration of 1975 as revised in 2013 Informed consent was obtained from patients prior to oral diagnostic examination
Inclusion criteria for ACS group
Patients diagnosed with both ACS and localized or generalized periodontitis of stage II or III with grade B or C
The diagnosis of ACS was performed by a consultant cardiologist based on clinical signs and symptoms of cardiac ischemia cardiac enzyme levels changes in electrocardiography and results of echocardiography and coronary angiography according to the guidelines of American College of CardiologyAmerican Heart Association The test group of ACS patients myocardial infarction NSTEMI and ST-segment elevation myocardial infarction STEMI were hospitalized in Selcuk University Meram Medical Faculty Department of Cardiology KonyaTurkeyUnstable angina UA was defined as the new onset or a changed pattern of angina over the past 2 months and Canadian Cardiovascular Society CCS class IV angina at the time of presentation coinciding with appropriate objective evidence of myocardial ischemia on an electrocardiogram ECG or myocardial perfusion imaging ACS with ST-segment elevation was defined as AMI characterized by chest pain radiating or not to the upper extremities lower jaw upper back or epigastrium lasting 30 minutes or more associated or not with sweating nausea or pallor presence of ST-segment elevation of 1 mm in two or more contiguous peripheral leads or 2 mm in two or more contiguous precordial leads on electrocardiogram ECG and elevation in serum markers of myocardial injury and necrosis CK CK-MB three times their reference value28 Non-ST-segment elevation ACS on ECG was defined as a clinical condition similar to that mentioned above but with chest pain lasting less than 30 minutes with or without elevation of serum enzyme markers of myocardial injury and necrosis CK CK-MB cardiac troponins I and T ACS patients were referred to the Department of Periodontology Faculty of Dentistry Selcuk University KonyaTurkey for periodontal examination in a one- year period
Inclusion criteria for control group
Patients diagnosed with localized or generalized periodontitis of stage II or III with grade B or C
Exclusions for both groups included
metabolic disorders
high blood pressure
treated with antihypertensive medications
periodontal therapy antibiotic treatment until 3 months prior the study Smoking habits and education status were also recorded ACS patients take aspirin 1 100 mg per day during 1 monthThis study was supported by grants from the Selcuk University Scientific Research Projects 05401018
Clinical Periodontal Examination All surviving individuals with ACS underwent a thorough periodontal examination approximately 1 month after treatment and hospital release All participants were evaluated for oral health clinically and radiographically The periodontal condition was graded based on the current classification method for periodontal diseases and subjects with localized or generalized periodontitis of stage II or III with grade B or C were selected Periodontal health status of patients was evaluated by plaque index PI papilla bleeding index probing depth PD and clinical attachment level CAL All probing scores were measured with Williams periodontal probe calibrated in millimeters Clinical attachment loss was determined relative to the cementoenamel junction Periodontal index was evaluated for risk of infectiousness PIRI scores
Gingival Crevicular Fluid Samples
At baseline GCF samples were collected for each subject from 4 distinct inter-proximal sites one site for each quadrant Sampling sites were chosen only at the buccal directions of the inter-proximal regions of molar teeth with PD more than 5 mm The four GCF samples for each subject in the two research groups were pooled to ensure sufficient sensitivity for each subject Consequently site-specific differences were not evaluated The same sites were sampled at 1 and 3 months following treatment Sites were isolated with cotton rolls gently dried with air syringe and the obvious supra-gingival plaque was carefully removed with a curette GCF was collected with prefabricated paper strips The strip was inserted into the pocket until mild resistance was felt and kept there for 30 seconds Contaminated samples with blood or saliva were discharged The volume of GCF was determined with Periotron 8000 previously calibrated with serum Four strips were pooled in a single tube containing 500microliter phosphate buffered saline PBS pH 74 and repeated for each patient The tubes were vortexed for 10 min and stored at -80 C until assayed
Inclusion criteria for ACS group
Patients diagnosed with both ACS and localized or generalized periodontitis of stage II or III with grade B or C
The diagnosis of ACS was performed by a consultant cardiologist based on clinical signs and symptoms of cardiac ischemia cardiac enzyme levels changes in electrocardiography and results of echocardiography and coronary angiography according to the guidelines of American College of CardiologyAmerican Heart Association The test group of ACS patients myocardial infarction NSTEMI and ST-segment elevation myocardial infarction STEMI were hospitalized in Selcuk University Meram Medical Faculty Department of Cardiology KonyaTurkeyUnstable angina UA was defined as the new onset or a changed pattern of angina over the past 2 months and Canadian Cardiovascular Society CCS class IV angina at the time of presentation coinciding with appropriate objective evidence of myocardial ischemia on an electrocardiogram ECG or myocardial perfusion imaging ACS with ST-segment elevation was defined as AMI characterized by chest pain radiating or not to the upper extremities lower jaw upper back or epigastrium lasting 30 minutes or more associated or not with sweating nausea or pallor presence of ST-segment elevation of 1 mm in two or more contiguous peripheral leads or 2 mm in two or more contiguous precordial leads on electrocardiogram ECG and elevation in serum markers of myocardial injury and necrosis CK CK-MB three times their reference value28 Non-ST-segment elevation ACS on ECG was defined as a clinical condition similar to that mentioned above but with chest pain lasting less than 30 minutes with or without elevation of serum enzyme markers of myocardial injury and necrosis CK CK-MB cardiac troponins I and T ACS patients were referred to the Department of Periodontology Faculty of Dentistry Selcuk University KonyaTurkey for periodontal examination in a one- year period
Inclusion criteria for control group
Patients diagnosed with localized or generalized periodontitis of stage II or III with grade B or C
Exclusions for both groups included
metabolic disorders
high blood pressure
treated with antihypertensive medications
periodontal therapy antibiotic treatment until 3 months prior the study Smoking habits and education status were also recorded ACS patients take aspirin 1 100 mg per day during 1 monthThis study was supported by grants from the Selcuk University Scientific Research Projects 05401018
Clinical Periodontal Examination All surviving individuals with ACS underwent a thorough periodontal examination approximately 1 month after treatment and hospital release All participants were evaluated for oral health clinically and radiographically The periodontal condition was graded based on the current classification method for periodontal diseases and subjects with localized or generalized periodontitis of stage II or III with grade B or C were selected Periodontal health status of patients was evaluated by plaque index PI papilla bleeding index probing depth PD and clinical attachment level CAL All probing scores were measured with Williams periodontal probe calibrated in millimeters Clinical attachment loss was determined relative to the cementoenamel junction Periodontal index was evaluated for risk of infectiousness PIRI scores
Gingival Crevicular Fluid Samples
At baseline GCF samples were collected for each subject from 4 distinct inter-proximal sites one site for each quadrant Sampling sites were chosen only at the buccal directions of the inter-proximal regions of molar teeth with PD more than 5 mm The four GCF samples for each subject in the two research groups were pooled to ensure sufficient sensitivity for each subject Consequently site-specific differences were not evaluated The same sites were sampled at 1 and 3 months following treatment Sites were isolated with cotton rolls gently dried with air syringe and the obvious supra-gingival plaque was carefully removed with a curette GCF was collected with prefabricated paper strips The strip was inserted into the pocket until mild resistance was felt and kept there for 30 seconds Contaminated samples with blood or saliva were discharged The volume of GCF was determined with Periotron 8000 previously calibrated with serum Four strips were pooled in a single tube containing 500microliter phosphate buffered saline PBS pH 74 and repeated for each patient The tubes were vortexed for 10 min and stored at -80 C until assayed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None