跳至主要内容
临床试验/CTRI/2026/03/106134
CTRI/2026/03/106134尚未招募Unknown

Effect of water flosser use compared with interdental brush on salivary IL-4 and IL-6 on plaque-induced gingivitis.

AB Shetty Memorial Institute of Dental Sciences1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
52
试验地点
1

研究概览

简要总结

This study titled "Effect of water flosser use compared with interdental brush on salivary IL-4 and IL-6 on plaque-induced gingivitis" aims to evaluate and compare effect of water flosser use in management of dental plaque and gingival inflammation as compared to interdental brush.Water flossers are oral irrigation devices that deliver pulsating streams of water to disrupt and flush out dental plaque and debris from interproximal and subgingival areas. In this study participants will be instructed to use a cordless water flosser (ORACURA Smart Water Flosser, Model OC150) once daily for interdental cleaning for a period of 4 weeks. The device will be standardized at a moderate pulsating pressure of approximately 60 PSI with a pulsation frequency of 1200–1800 pulses per minute. Several clinical studies have reported improvements in gingival inflammation and plaque control with the use of water flossers. However, most of the available evidence is based primarily on clinical indices, and there is limited research evaluating the biological or inflammatory response associated with their use. Salivary biomarkers provide a non-invasive method to assess inflammatory changes in periodontal tissues. Interleukin-6 (IL-6) is a pro-inflammatory cytokine involved in the progression of gingival inflammation, while Interleukin-4 (IL-4) is an anti-inflammatory cytokine associated with immune modulation. Changes in the salivary levels of these biomarkers can reflect the inflammatory status of gingival tissues and the response to oral hygiene interventions.

This single-blind randomized controlled clinical trial will be conducted among patients with plaque-induced gingivitis attending the outpatient department of Periodontology at AB Shetty Memorial Institute of Dental Sciences. A total of 52 participants will be randomly allocated into two groups: water flosser group and interdental brush group. Clinical parameters including Plaque Index, Gingival Index, and Bleeding on Probing will be assessed at baseline and 4 weeks. Salivary samples will be collected and analysed for IL-4 and IL-6 levels using ELISA. The study aims to evaluate and compare the clinical and inflammatory effects of water flosser and interdental brush in the management of plaque-induced gingivitis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Adults between 18-40 years of age with plaque induced gingivitis.
  • Patients with periodontal pocket depth less than 3mm and no clinical attachment loss.
  • Patients willing for participation and have provided written consent.

排除标准

  • Patients suffering from systemic diseases, which may have an impact on the periodontium, such as diabetes mellitus and osteoporosis.
  • Unco-operative patients
  • Patients on antibiotics and/or anti-inflammatory drugs.
  • Patients with periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession
  • Pregnant and lactating mothers
  • Smokers and smokeless tobacco users.
  • Patient with orthodontic appliance or prosthetic appliance.

研究者

发起方
AB Shetty Memorial Institute of Dental Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nikita Nagaraj Hoskeri

A B Shetty Memorial institute of Dental Sciences

研究点 (1)

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