980nm Diode Laser in the Treatment of Periodontal Disease in Cardiac Patients

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145557
• Other study ID #: KB-0012/06/12 KB-0012/09/1
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: May 28, 2020

Study information

• Verified date: March 2020
• Source: Pomeranian Medical University Szczecin
• Contact: Renata Samulak, PhD
• Phone: 48914661745
• Email: renata.samulak.zielinska[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 28, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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:

1. Acute inflammation of the airways or urinary tract

2. Neoplasmas

3. Rheumatic diseases

4. Autoimmune diseases

5. Chronic liver disease

6. Chronic kidney failure 4. and 5. stage

7. History of a stroke or TIA

8. Lack of consent for participation in the study

9. Antibiotic therapy in the last 12 months

10. Periodontal treatment in the last 6 months

11. Participation in other studies

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Periodontal Diseases

Intervention

Device:
• diode laser 980nm
Procedure: Periodontal therapy with laser Scaling, root planning, oral hygiene instruction and diode laser 980nm treatment of periodontal pockets
• scaling root planing
scaling and root planing

Locations

Country	Name	City	State
Poland	Departament of Periodontology	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD	periodontal pocket depht	up to 3 months
Primary	Bacterial count	level in periodontal pocket	up to 3 months
Primary	hsCRP	level in serum	up to 3 months
Secondary	CAL	clinical attachment level	december 2019
Secondary	BOP	bleeding on probing	up to 3 months
Secondary	elastase	level in serum and gingival fluid	up to 3 months
Secondary	fibrynogen	level in serum	up to 3 months
Secondary	Il-6	level in serum and gingival fluid	up to 3 months
Secondary	glucose	level in serum	up to 3 months
Secondary	HDL	level in serum	up to 3 months
Secondary	LDL	level in serum	up to 3 months
Secondary	TCH	level in serum	up to 3 months
Secondary	TG	level in serum	up to 3 months
Secondary	AST	level in serum	up to 3 months
Secondary	ALT	level in serum	up to 3 months
Secondary	GCF	gingival cervicular fluid	up to 3 months