Clinical trial NCT04908098: Diode Laser Application With Non-Surgical Periodontal Treatment
Official title: Clinical and Biochemical Evaluation of the Effectiveness of Diode Laser Application With Non-Surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
Gingival crevicular fluid
diode laser
sclerostin
TWEAK
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were divided into two groups as study and control.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: The secondary outcome of the study is the recording of bleeding index in the 3rd month.
timeFrame: 3 months
measure: Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
timeFrame: 3 months
measure: The secondary outcome of the study is a measure of the clinical attachment level.
timeFrame: 3 months
measure: The secondary outcome of the study is the recording of gingival index in the 3rd month.
timeFrame: 3 months
measure: The secondary outcome of the study is the recording of plaque index in the 3rd month.
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe Universty
Study officials:
affiliation: Principal Investigator
name: Ali Tuğrul Gür, Dentist
role: PRINCIPAL_INVESTIGATOR
affiliation: study director
name: Güliz Nigar Güncü, Professor
role: STUDY_DIRECTOR
affiliation: Study principal investigator
name: Abdullah Cevdet Akman, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: study principal investigator
name: Rahime Meral Nohutcu, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: biochemistry
name: Aslı Pınar, Professor
role: PRINCIPAL_INVESTIGATOR
References: