Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04145557
Status:
UNKNOWN
Last Update Posted:
2020-03-05
First Post:
2019-10-24
Brief Title:
980nm Diode Laser in the Treatment of Periodontal Disease in Cardiac Patients
Sponsor:
Pomeranian Medical University Szczecin
Organization:
Pomeranian Medical University Szczecin
Study Overview
Official Title:
The Effect of Periodontal Treatment With 980nm Diode Laser on the State of Periodontium and Inflammatory Markers in Generally Healthy Patients and Patients After Myocardial Infarction
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
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:
The study will cover 80 patients under 70 years of age Initially they will be assigned to three groups patients generally healthy with periodontitis P patients after myocardial infarction with periodontitis CP and patients generally healthy with a healthy periodontium H Periodontal examination will be performed before treatment 2 weeks and 3 months after the treatment with a Williams probe calibrated at intervals 1-2-3-5-7-8-9-10mm Pocket depth PD clinical loss of the attachment CAL bleeding on probing BOP plaque control record PCR measurements will be performed Clinical data will be collected at six sites per tooth mesiobuccal midbuccal distobuccal mesiolingual midlingual and distolingual of the designated study teeth PD will be measured in millimeters from the free gingival margin to the base of the probable pocket using a periodontal probe The presence of BOP will be determined as being present or absent - within 30 seconds after probing CAL will be defined as the distance from the cementoenamel junction to t the base of the probable pocket
Patients within CP and P groups will be randomly assigned to one of the two groups study group and control group and an later visit will be scheduled
Before treatment teeth will be rinsed and the study areas will be isolated with cotton rolls and dried gently Supragingival plaque will then be removed with a sterile curret without coming into contact with the gingiva GCF samples will be collected from the deepest single root tooth pockets previously identified The sample will be collected from the deepest pocket using the Periopaper strips OraflowInc USA Before collecting the material the teeth will be insulated with cotton swabs The teeth will then be dried with air The strips will be placed in pockets until a slight resistance is perceived and they will be left in place for 30 seconds and then transferred to Periotron 8000 OraflowInc USA for the determination of fluid volume Strips contaminated by bleeding will be discarded
Next each strip will be inserted into the Eppendorff tube and sent to the laboratory at the Medical Analytics Department of PUM in Szczecin for further analysis The volume of the gingival fluid will be given in μl in accordance with the conversion of values displayed as a reading on the device
The microbiological examination via Real-PCR method for the presence of pathogenic bacteria for periodontium will be performed using commercial standard sets PET-MIP deluxe MIP Pharma Samples will be taken from the patients deepest periodontal pocket After isolation of the examined tooth from the access of saliva sterile paper will be placed inside the pocket for 10 seconds following transfer to the transport containers included in the PET-Mip deluxe kits and sent to the MIP-Pharma laboratory in St Ingbert in Germany
In the control and study group supra and subgingival scaling and root smoothing with Gracey currets will be performed Individual oral hygiene instructions will also be given to each patient In addition laser therapy of the pockets with a 980nm diode laser will be carried out in the study group
The levels of TC LDL HDL TG hsCRP leukocytes fibrinogen OB IL-6 AST ALT in the peripheral blood will be marked three times before treatment 2 weeks and 3 months post treatment For this purpose the blood will be taken from the superficial veins of the forearm and sent for further analysis at the Medical Analytics Department of PUM in Szczecin
Patients within CP and P groups will be randomly assigned to one of the two groups study group and control group and an later visit will be scheduled
Before treatment teeth will be rinsed and the study areas will be isolated with cotton rolls and dried gently Supragingival plaque will then be removed with a sterile curret without coming into contact with the gingiva GCF samples will be collected from the deepest single root tooth pockets previously identified The sample will be collected from the deepest pocket using the Periopaper strips OraflowInc USA Before collecting the material the teeth will be insulated with cotton swabs The teeth will then be dried with air The strips will be placed in pockets until a slight resistance is perceived and they will be left in place for 30 seconds and then transferred to Periotron 8000 OraflowInc USA for the determination of fluid volume Strips contaminated by bleeding will be discarded
Next each strip will be inserted into the Eppendorff tube and sent to the laboratory at the Medical Analytics Department of PUM in Szczecin for further analysis The volume of the gingival fluid will be given in μl in accordance with the conversion of values displayed as a reading on the device
The microbiological examination via Real-PCR method for the presence of pathogenic bacteria for periodontium will be performed using commercial standard sets PET-MIP deluxe MIP Pharma Samples will be taken from the patients deepest periodontal pocket After isolation of the examined tooth from the access of saliva sterile paper will be placed inside the pocket for 10 seconds following transfer to the transport containers included in the PET-Mip deluxe kits and sent to the MIP-Pharma laboratory in St Ingbert in Germany
In the control and study group supra and subgingival scaling and root smoothing with Gracey currets will be performed Individual oral hygiene instructions will also be given to each patient In addition laser therapy of the pockets with a 980nm diode laser will be carried out in the study group
The levels of TC LDL HDL TG hsCRP leukocytes fibrinogen OB IL-6 AST ALT in the peripheral blood will be marked three times before treatment 2 weeks and 3 months post treatment For this purpose the blood will be taken from the superficial veins of the forearm and sent for further analysis at the Medical Analytics Department of PUM in Szczecin
Detailed Description:
The study will cover 80patients under 70 years of age Initially they will be assigned to three groups patients generally healthy with periodontitis P patients after myocardial infarction with periodontitis CP and patients generally healthy with a healthy periodontium H Periodontal examination will be performed before treatment 2 weeks and 3 months after the treatment with a Williams probe calibrated at intervals 1-2-3-5-7-8-9-10mm Pocket depth PD clinical loss of the attachment CAL bleeding on probing BOP plaque control record PCR measurements will be performed Clinical data will be collected at six sites per tooth mesiobuccal midbuccal distobuccal mesiolingual midlingual and distolingual of the designated study teeth PD will be measured in millimeters from the free gingival margin to the base of the probable pocket using a periodontal probe The presence of BOP will be determined as being present or absent - within 30 seconds after probing CAL will be defined as the distance from the cementoenamel junction to t the base of the probable pocket
Patients within CP and P groups will be randomly assigned to one of the two groups study group and control group and an later visit will be scheduled
Before treatment teeth will be rinsed and the study areas will be isolated with cotton rolls and dried gently Supragingival plaque will then be removed with a sterile curret without coming into contact with the gingiva GCF samples will be collected from the deepest single root tooth pockets previously identified The sample will be collected from the deepest pocket using the Periopaper strips OraflowInc USA Before collecting the material the teeth will be insulated with cotton swabs The teeth will then be dried with air The strips will be placed in pockets until a slight resistance is perceived and they will be left in place for 30 seconds and then transferred to Periotron 8000 OraflowInc USA for the determination of fluid volume Strips contaminated by bleeding will be discarded
Next each strip will be inserted into the Eppendorff tube and sent to the laboratory at the Medical Analytics Department of PUM in Szczecin for further analysis The volume of the gingival fluid will be given in μl in accordance with the conversion of values displayed as a reading on the device
The microbiological examination via Real-PCR method for the presence of pathogenic bacteria for periodontium will be performed using commercial standard sets PET-MIP deluxe MIP Pharma Samples will be taken from the patients deepest periodontal pocket After isolation of the examined tooth from the access of saliva sterile paper will be placed inside the pocket for 10 seconds following transfer to the transport containers included in the PET-Mip deluxe kits and sent to the MIP-Pharma laboratory in St Ingbert in Germany
In the control and study group supra and subgingival scaling and root smoothing with Gracey currets will be performed Individual oral hygiene instructions will also be given to each patient In addition laser therapy of the pockets with a 980nm diode laser will be carried out in the study group
The levels of TC LDL HDL TG hsCRP leukocytes fibrinogen OB IL-6 AST ALT in the peripheral blood will be marked three times before treatment 2 weeks and 3 months post treatment For this purpose the blood will be taken from the superficial veins of the forearm and sent for further analysis at the Medical Analytics Department of PUM in Szczecin
Patients within CP and P groups will be randomly assigned to one of the two groups study group and control group and an later visit will be scheduled
Before treatment teeth will be rinsed and the study areas will be isolated with cotton rolls and dried gently Supragingival plaque will then be removed with a sterile curret without coming into contact with the gingiva GCF samples will be collected from the deepest single root tooth pockets previously identified The sample will be collected from the deepest pocket using the Periopaper strips OraflowInc USA Before collecting the material the teeth will be insulated with cotton swabs The teeth will then be dried with air The strips will be placed in pockets until a slight resistance is perceived and they will be left in place for 30 seconds and then transferred to Periotron 8000 OraflowInc USA for the determination of fluid volume Strips contaminated by bleeding will be discarded
Next each strip will be inserted into the Eppendorff tube and sent to the laboratory at the Medical Analytics Department of PUM in Szczecin for further analysis The volume of the gingival fluid will be given in μl in accordance with the conversion of values displayed as a reading on the device
The microbiological examination via Real-PCR method for the presence of pathogenic bacteria for periodontium will be performed using commercial standard sets PET-MIP deluxe MIP Pharma Samples will be taken from the patients deepest periodontal pocket After isolation of the examined tooth from the access of saliva sterile paper will be placed inside the pocket for 10 seconds following transfer to the transport containers included in the PET-Mip deluxe kits and sent to the MIP-Pharma laboratory in St Ingbert in Germany
In the control and study group supra and subgingival scaling and root smoothing with Gracey currets will be performed Individual oral hygiene instructions will also be given to each patient In addition laser therapy of the pockets with a 980nm diode laser will be carried out in the study group
The levels of TC LDL HDL TG hsCRP leukocytes fibrinogen OB IL-6 AST ALT in the peripheral blood will be marked three times before treatment 2 weeks and 3 months post treatment For this purpose the blood will be taken from the superficial veins of the forearm and sent for further analysis at the Medical Analytics Department of PUM in Szczecin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None