Diode Laser Application With Non-Surgical Periodontal Treatment

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04908098
• Other study ID #: TSA-2019-18111
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2019
• Est. completion date: August 10, 2021

Study information

• Verified date: May 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe Universty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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