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Clinical Trials/NCT04908098
NCT04908098
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Clinical and Biochemical Evaluation of the Effectiveness of Diode Laser Application With Non-Surgical Periodontal Treatment

Hacettepe University1 site in 1 country40 target enrollmentNovember 10, 2019
ConditionsPeriodontitis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Hacettepe University
Enrollment
40
Locations
1
Primary Endpoint
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
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2019
End Date
August 10, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ali Tugrul Gur

principal investigator, research assistant

Hacettepe University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 3 months

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.

Secondary Outcomes

  • Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.(3 months)
  • The secondary outcome of the study is the recording of bleeding index in the 3rd month.(3 months)
  • The secondary outcome of the study is a measure of the clinical attachment level.(3 months)
  • The secondary outcome of the study is the recording of gingival index in the 3rd month.(3 months)
  • The secondary outcome of the study is the recording of plaque index in the 3rd month.(3 months)

Study Sites (1)

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