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临床试验/NCT04908098
NCT04908098Unknown不适用

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

Hacettepe University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2019年11月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Tugrul Gur

principal investigator, research assistant

Hacettepe University

研究点 (2)

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