Diode Laser Application With Non-Surgical Periodontal Treatment

Clinical and Biochemical Evaluation of the Effectiveness of Diode Laser Application With Non-Surgical Periodontal Treatment

Periodontitis is an infectious disease that causes destruction of periodontal tissues with complex etiology that develops due to local and systemic factors. Host-derived enzymes, cytokines and proinflammatory markers are the main elements that play a role in this degradation. New techniques such as non-surgical or surgical methods combined with laser application are used for its treatment.

The subjects were divided into two groups as "Individuals Applied with Diode Laser in Addition to Non-Surgical Periodontal Treatment" (Laser group) and "Individuals with Non-Surgical Periodontal Treatment (SRP)" (Control group). While only non-surgical periodontal treatment was applied to individuals in the control group; In the laser group, diode laser was applied in addition to this treatment. All individuals were examined 1 and 3 months after treatment.The scaling root planing (SRP) procedure was performed mechanically with gracey curettes under local anesthesia. The diode laser applied to the study group was applied parallel to the gingival sulcus at 0.80W power, 940 nm wavelength and 0.80 J / s energy level in continuous phase. Gingival crevicular fluid (GCF) samples were taken without any procedure in order not to change the amount and content. All clinical parameters were also measured by the same investigator before SRP and in all participants. After this treatment, the participants were re-examined in the 1st and 3rd months for control purposes and GCF samples were taken from the same regions again and the clinical parameters were measured again by the same researcher. GCF samples were stored at -20 degrees Celsius until ELISA studies were performed. Clinical parameters (pocket depth, clinical attachment loss, bleeding on probing, gingival index, plaque index) and gingival crevicular fluid (GCF) sampling were obtained at each control. IL-1β, IL-10, IL-17, OPG, RANKL, TWEAK, Sclerostin levels in GCF samples were measured with ELISA method.

The aim of this study is to evaluate the effectiveness of diode laser application in addition to non-surgical treatment in periodontitis treatment clinically and biochemically and to assess the potential biomarkers for use.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Device: diode laser; Procedure: scaling - root planning

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

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Presence of 5mm or more periodontal pockets on one or more surfaces in periodontal tissues,
2. Not having periodontal treatment in the last 3 months,
3. The informed consent form must be approved,
4. At least 18 years old.

Exclusion Criteria:

1. Presence of systemic disease,
2. Smoking,
3. Regular use of non-steroidal anti inflammatory drugs,
4. Having been treated with antibiotics in the last 3 months,
5. Individuals in need of pre-treatment antibiotic prophylaxis,
6. Pregnancy and lactation,
7. Not approving the informed consent form,
8. Patients with known allergies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser group; Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling. Laser application was then applied to the areas where root planning was applied. Laser was applied in continuous phase at 0.80W power, 940 nm wavelength and 0.80 J / s energy level.	Device: diode laser; It is the application of the laser tip parallel to the inner surface of the periodontal pocket; Procedure: scaling - root planning; Scaling is the removal of calculus and other deposits in the root of the tooth.Root planning is the removal of necrotic cementum on the tooth root surface. Scaler and gracey curettes are used for these operations.
Active Comparator: Control group; Root-planning was performed using Gracey curettes in the areas where periodontal pockets were diagnosed after scaling.	Procedure: scaling - root planning; Scaling is the removal of calculus and other deposits in the root of the tooth.Root planning is the removal of necrotic cementum on the tooth root surface. Scaler and gracey curettes are used for these operations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome of the study was the control examination performed 3 months after the first examination. At the 3rd month control, the same researcher measured clinical parameters from all patients	Probing depth is the measurement from the free gingival margin, to the base of the pocket in millimeters of the distance. Periodontal probe is used.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome of the study is the recording of bleeding index in the 3rd month.	The bleeding index is evaluated as positive if there is bleeding in the gingiva during probing.	3 months
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.	Samples are obtained by means of paper strips placed gently in the gingival groove. These samples are stored at -20 ° C for later analysis by ELISA method.	3 months
The secondary outcome of the study is a measure of the clinical attachment level.	The distance in millimeters from the cemento enamel junction to the bottom of the pocket.	3 months
The secondary outcome of the study is the recording of gingival index in the 3rd month.	The gingival index is graded as follows: 0 = Normal gingiva; = Mild inflammationslight change in color, slight oedema. No bleeding on probing; = Moderate inflammation redness, oedema and glazing. Bleeding on probing; = Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.	3 months
The secondary outcome of the study is the recording of plaque index in the 3rd month.	The plaque index is graded as follows: 0 = No plaque in the gingival area.; = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.; = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.; = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.	3 months

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Ali Tuğrul Gür, Dentist, Principal Investigator; Study Director: Güliz Nigar Güncü, Professor, Study Director; Principal Investigator: Abdullah Cevdet Akman, professor, Study Principal Investigator; Principal Investigator: Rahime Meral Nohutcu, professor, Study Principal Investigator; Principal Investigator: Aslı Pınar, Professor, biochemistry

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2019
• Primary Completion (Actual): August 10, 2020
• Study Completion (Anticipated): August 10, 2021

Study Registration Dates

• First Submitted: May 8, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: periodontitis; Gingival crevicular fluid; diode laser; sclerostin; TWEAK
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: TSA-2019-18111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual data of the participants will not be shared. Statistical analysis of the study will be shared.

Drug and device information, study documents

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