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临床试验/NCT07822269
NCT07822269招募中不适用

Comparison of the Effectiveness of Dental Loupe and Dental Operating Microscope in Non-Surgical Periodontal Treatment

Saglik Bilimleri Universitesi3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
3
主要终点
Total microbial load

研究概览

简要总结

Periodontitis is a multifactorial, non-infectious disease that can lead to tooth loss if left untreated. Advanced stages of periodontitis can affect chewing ability, nutritional status, and quality of life. Calculus removal, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, patients who undergo calculus removal and root planing followed by regular maintenance programs experience less tooth loss and clinical attachment loss. Calculus removal and root planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces. The use of magnification systems to increase the field of view in both surgical and non-surgical procedures dates back to the 1860s with the first use of surgical microscopes. Magnification systems were first used in dentistry in the first half of the 20th century. In 1978, Apotheker and Jako developed the first surgical microscope for use in dentistry. The use of magnifying loupes as visual aids by dentists has become increasingly popular over the years, with continuous improvements in design and effectiveness. A 2019 survey among dentists indicated that magnifying lenses are one of the significant technological advancements in this profession. Periodontal endoscopy is also one of the approaches clinicians use to improve visibility. Dental magnification systems are known to increase effectiveness, especially in interproximal areas where access and visibility are limited. Clinical studies have compared root surface planing procedures performed with periodontal endoscopy with traditional root surface planing. The results of the studies showed a significant difference in clinical outcomes in patients treated with periodontal endoscopy compared to those treated with traditional methods. The aim of this study is to analyze the clinical and microbiological benefits of image magnification systems (dental loupe and dental microscope) in scaling and root surface planing in the treatment of patients with periodontitis.

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

  • Being over 18 years of age
  • Being systemically healthy
  • Having at least 20 permanent teeth in both upper and lower jaws
  • Having periodontitis
  • Having the mental capacity to understand the research objectives and methods to be applied as explained in writing and orally
  • Being convinced that the volunteer will be suitable and cooperative with the physician-patient before, during and after the procedure
  • Not having any physical or psychological condition that would prevent mechanical debridement
  • Not being a bacterial or viral carrier

排除标准

  • Patients under 18 years of age
  • Patients who are periodontally healthy
  • Smoking more than 10 cigarettes a day
  • Having received periodontal treatment within the last year
  • Having used antibiotics within the last 3 months
  • Being pregnant or breastfeeding
  • Those with diabetes, chronic kidney failure, cancer, bleeding disorders, connective tissue diseases, and similar chronic diseases

研究组 & 干预措施

Dental Loupe

Experimental

A split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental loupe which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate.

干预措施: Mechanical debridement and dental plaque sample collection with dental loupe (Procedure)

Dental Microscope

Experimental

A split-mouth study design was planned for the same patient. The patient's right or left upper or lower jaw would be treated with a dental microscope which determined by a coin toss. Patients diagnosed with periodontitis (Stage 3-Grade A) in the periodontology clinic and undergoing routine non-surgical periodontal treatment would be included in the study if they voluntarily agreed to participate.

干预措施: Mechanical debridement and dental plaque sample collection with dental microscope (Procedure)

结局指标

主要结局

Total microbial load

时间窗: At enrollment. and 1 month control visit

To determine the amount of microorganisms, plaque samples taken from each patient will be stored in Eppendorf tubes at -80°C with sterile distilled water until microbial analysis is performed. Plaque samples stored at -80°C in Eppendorf tubes will be transported to the laboratories where microbiological examination will be performed using personal vehicles in dry ice thermal storage bags. DNA isolation from all suture samples will be performed using the High Pure PCR Template according to the manufacturer's instructions. The DNA will be stored at 80°C until the process is complete. The 16S rRNA gene will be detected by qPCR and the total bacterial count will be determined. Real-time PCR procedures will be performed on a LightCycler 480 II system using the Fast Start Essential DNA Green Master Mix Kit according to the manufacturer's instructions.

Probing Pocket Depth

时间窗: At enrollment, 1 and 3 months control visits

Probing pocket depth, or probing depth, is a numerical value obtained by measuring the distance between the gingival margin and the gingival sulcus/pocket floor using a standard periodontal probe with a tip approximately 0.4-0.5 mm in diameter, and rounding the measurement to the nearest millimeter.

次要结局

  • Gingival Index(At enrollment, 1 and 3 months control visits)
  • Papillary Bleeding Index(At enrollment, 1 and 3 months control visits)
  • Plaque Index (PI/ Turesky Gilmore Glickman modification of the Quingley Hein plaque index)(At enrollment, 1 and 3 months control visits)
  • Gingival Bleeding Index (Ainamo & Bay)(At enrollment, 1 and 3 month control visits)
  • Clinical attachment loss(At enrollment, 1 and 3 months control visits)

研究者

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

Tuğçe Paksoy

Associate Professor

Saglik Bilimleri Universitesi

研究点 (3)

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