980nm Diode Laser in the Treatment of Periodontal Disease in Cardiac Patients
Primary Purpose
Myocardial Infarction, Periodontal Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
diode laser 980nm
scaling root planing
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring periodontitis, diode laser, Myocardial infarction
Eligibility Criteria
Inclusion Criteria:
1. myocardial infarction treated with primary coronary angioplasty in the last 6 months, 2. age <65 years 3. Periodontitis diagnosed according to Page criterion -
- ≥ 2 tooth surfaces on interprimimal spaces with a loss of CAL≥4mm (not for the same tooth)
- ≥2 tooth surface in the interpharmal space with PD≥4mm
- positive bleeding on probing test (BOP) 4. signed informed consent
Exclusion Criteria:
- Acute inflammation of the airways or urinary tract
- Neoplasmas
- Rheumatic diseases
- Autoimmune diseases
- Chronic liver disease
- Chronic kidney failure 4. and 5. stage
- History of a stroke or TIA
- Lack of consent for participation in the study
- Antibiotic therapy in the last 12 months
- Periodontal treatment in the last 6 months
- Participation in other studies
Sites / Locations
- Departament of PeriodontologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
skaling root planing
skaling root planing and diode laser
Arm Description
Outcomes
Primary Outcome Measures
PD
periodontal pocket depht
Bacterial count
level in periodontal pocket
hsCRP
level in serum
Secondary Outcome Measures
CAL
clinical attachment level
BOP
bleeding on probing
elastase
level in serum and gingival fluid
fibrynogen
level in serum
Il-6
level in serum and gingival fluid
glucose
level in serum
HDL
level in serum
LDL
level in serum
TCH
level in serum
TG
level in serum
AST
level in serum
ALT
level in serum
GCF
gingival cervicular fluid
Full Information
NCT ID
NCT04145557
First Posted
October 24, 2019
Last Updated
March 4, 2020
Sponsor
Pomeranian Medical University Szczecin
1. Study Identification
Unique Protocol Identification Number
NCT04145557
Brief Title
980nm Diode Laser in the Treatment of Periodontal Disease in Cardiac Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 28, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 patient's 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 patient's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Periodontal Diseases
Keywords
periodontitis, diode laser, Myocardial infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
skaling root planing
Arm Type
Placebo Comparator
Arm Title
skaling root planing and diode laser
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
diode laser 980nm
Intervention Description
Procedure: Periodontal therapy with laser Scaling, root planning, oral hygiene instruction and diode laser 980nm treatment of periodontal pockets
Intervention Type
Device
Intervention Name(s)
scaling root planing
Intervention Description
scaling and root planing
Primary Outcome Measure Information:
Title
PD
Description
periodontal pocket depht
Time Frame
up to 3 months
Title
Bacterial count
Description
level in periodontal pocket
Time Frame
up to 3 months
Title
hsCRP
Description
level in serum
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
CAL
Description
clinical attachment level
Time Frame
december 2019
Title
BOP
Description
bleeding on probing
Time Frame
up to 3 months
Title
elastase
Description
level in serum and gingival fluid
Time Frame
up to 3 months
Title
fibrynogen
Description
level in serum
Time Frame
up to 3 months
Title
Il-6
Description
level in serum and gingival fluid
Time Frame
up to 3 months
Title
glucose
Description
level in serum
Time Frame
up to 3 months
Title
HDL
Description
level in serum
Time Frame
up to 3 months
Title
LDL
Description
level in serum
Time Frame
up to 3 months
Title
TCH
Description
level in serum
Time Frame
up to 3 months
Title
TG
Description
level in serum
Time Frame
up to 3 months
Title
AST
Description
level in serum
Time Frame
up to 3 months
Title
ALT
Description
level in serum
Time Frame
up to 3 months
Title
GCF
Description
gingival cervicular fluid
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. myocardial infarction treated with primary coronary angioplasty in the last 6 months, 2. age <65 years 3. Periodontitis diagnosed according to Page criterion -
≥ 2 tooth surfaces on interprimimal spaces with a loss of CAL≥4mm (not for the same tooth)
≥2 tooth surface in the interpharmal space with PD≥4mm
positive bleeding on probing test (BOP) 4. signed informed consent
Exclusion Criteria:
Acute inflammation of the airways or urinary tract
Neoplasmas
Rheumatic diseases
Autoimmune diseases
Chronic liver disease
Chronic kidney failure 4. and 5. stage
History of a stroke or TIA
Lack of consent for participation in the study
Antibiotic therapy in the last 12 months
Periodontal treatment in the last 6 months
Participation in other studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renata Samulak, PhD
Phone
48914661745
Ext
48914661745
Email
renata.samulak.zielinska@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dembowska Elżbieta
Phone
48914661745
Ext
48914661745
Email
zperio@pum.edu.pl
Facility Information:
Facility Name
Departament of Periodontology
City
Szczecin
ZIP/Postal Code
70-204
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Samulak, PhD
First Name & Middle Initial & Last Name & Degree
Renata Samulak, PhD
First Name & Middle Initial & Last Name & Degree
Elżbieta Dembowska, prof
First Name & Middle Initial & Last Name & Degree
Mariusz Suwała, PhD
First Name & Middle Initial & Last Name & Degree
Piotr Lizakowski, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Documentation of study participants in paper form will be kept at the Department of Periodontology. We provide information on aggregate results in tables and statistical analysis after contact by email.
Citations:
PubMed Identifier
32885341
Citation
Samulak R, Suwala M, Dembowska E. Nonsurgical periodontal therapy with/without 980 nm diode laser in patients after myocardial infarction: a randomized clinical trial. Lasers Med Sci. 2021 Jul;36(5):1003-1014. doi: 10.1007/s10103-020-03136-6. Epub 2020 Sep 4.
Results Reference
derived
Learn more about this trial
980nm Diode Laser in the Treatment of Periodontal Disease in Cardiac Patients
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