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临床试验/NCT07650747
NCT07650747已完成不适用

Effectiveness of the Touch-to-Teach Method for Interdental Brushing in Patients With Stage II Grade B Periodontitis. A Randomized Clinical Trial

Gulf Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1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
已完成
发起方
入组人数
40
试验地点
1
主要终点
Plaque index

研究概览

简要总结

In 2018, a collaboration between American Academy of Periodontology (AAP) and European Federation of Periodontology (EFP) yielded a new classification system for periodontal diseases and conditions. The new classification categorized periodontitis into stages from I to IV based on the severity of the disease. Besides the stages, cases were also categorized into A, B and C grades based on the probable progression of the disease. Likewise, cases with interproximal clinical attachment loss of 3-4 mm in the worst affected teeth are considered to be stage II periodontitis.[3] These patients usually do not have tooth loss, can be suffering from localized or generalized type and mostly show horizontal bone loss. There are three types of gingival embrasures. In type I embrasure, the gingival embrasure is filled by the interproximal papilla; whereas in type II and III embrasures interdental papilla loss is seen. Interdental brushing has a vital role in maintaining good oral hygiene and previously published reports have evidenced that successful interdental brushing eliminated interdental plaque below the gingival margin up to 2-2.5 mm. According to the old school of thought, dental floss was advised for type I embrasures, interdental brushes for type II embrasures and unitufted brushes for type III embrasures. Usage of dental floss has been identified to be cumbersome and especially challenging in posterior regions of the oral cavity. Additionally, a recent systematic review in the Cochrane database highlighted the effectiveness of interproximal brushes over dental floss.[9] Recently, the implementation of calibrated interdental brushes use with the availability of interdental brushes with varying sizes, added effectively in creating a healthy interdental papilla in a safe manner. Essentially, a patient-centered and personalized approach named "individually trained oral prophylaxis (iTOP)" has recently been suggested as a solution to remove dental plaque effectively.[10] This concept known as the "Touch-to-Teach" concept provides the patients with an effective method to educate the patients an effective and non-traumatic way of removing interdental plaque.[10] Although, the effectiveness of calibrated interdental brushes showed high efficacy in cases of gingivitis, currently, the effectiveness of these brushes in stage II periodontitis has not been comprehensively studied yet in literature.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with generalized Stage II periodontitis, diagnosed based on the 2018 classification of periodontal diseases and conditions.[7]
  • Patients with presence of interproximal clinical attachment loss of ≥ 3-4 mm was used for the diagnosis of periodontitis.
  • Patients with more than 30% of sites with true periodontal pockets of more than 4 mm with bleeding on probing in the interproximal region.

排除标准

  • Patients with uncontrolled diabetes mellitus,
  • Patients smoking ≥ 10 cigarettes per day.
  • Patients who have undergone scaling and root debridement within the past six months
  • Patients who were on antimicrobial therapy in the past three months
  • Patients who were on regular use of anti-plaque mouth rinses in the past three months

研究组 & 干预措施

Interproximal standard hygiene care control group:

Active Comparator

The control group was provided with standard oral hygiene instructions (Bass method) and videos regarding maintenance of interdental oral hygiene were provided. Videos regarding oral hygiene maintenance were downloaded from the website of the EFP. Briefly, these animated videos are generated from PerioPixel, which specializes in the generation of animated videos in dentistry, explaining the different oral hygiene techniques and treatments for gingival and periodontal diseases.

干预措施: Interproximal standard hygiene care control group (Procedure)

Interproximal "Touch-to-Teach" method hygiene care test group

Experimental

The test group received interdental hygiene care using the "Touch-to-Teach" method. The Curaprox chairside system includes a range of color-coded interdental brushes selected according to the size of the patient's interdental spaces. The brushes are color-coded as blue, red, pink, yellow, and green, with blue with an interdental accessibility diameter of 0.6m, 0.7 mm, 0.8 mm, 0.9 mm, and 1.1 mm respectively . The kit also contains color-coded colorimetric probes (interdental access probes) that can be used to measure the size of the interproximal space.

干预措施: Interproximal "Touch-to-Teach" method hygiene care test group (Procedure)

结局指标

主要结局

Plaque index

时间窗: baseline and 3 months

次要结局

  • Bleeding index(baseline and 3 months)
  • Patient Satisfaction VAS scale 0-5(3 months)

研究者

发起方
Gulf Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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