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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Periodontal Diseases
• Intervention / Treatment: Device: scaling root planing; Device: diode laser 980nm

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Szczecin, Poland, 70-204
    • Departament of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: skaling root planing	Device: scaling root planing; scaling and root planing
Active Comparator: skaling root planing and diode laser	Device: diode laser 980nm; Procedure: Periodontal therapy with laser Scaling, root planning, oral hygiene instruction and diode laser 980nm treatment of periodontal pockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD	periodontal pocket depht	up to 3 months
Bacterial count	level in periodontal pocket	up to 3 months
hsCRP	level in serum	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAL	clinical attachment level	december 2019
BOP	bleeding on probing	up to 3 months
elastase	level in serum and gingival fluid	up to 3 months
fibrynogen	level in serum	up to 3 months
Il-6	level in serum and gingival fluid	up to 3 months
glucose	level in serum	up to 3 months
HDL	level in serum	up to 3 months
LDL	level in serum	up to 3 months
TCH	level in serum	up to 3 months
TG	level in serum	up to 3 months
AST	level in serum	up to 3 months
ALT	level in serum	up to 3 months
GCF	gingival cervicular fluid	up to 3 months

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Myocardial infarction; periodontitis; diode laser
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Periodontitis; Myocardial Infarction; Periodontal Diseases; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Semiconductor
• Other Study ID Numbers: KB-0012/06/12 KB-0012/09/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No