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临床试验/CTRI/2025/09/095193
CTRI/2025/09/095193尚未招募不适用

Comparative evaluation of efficacy of iontophoresis in the treatment of dentinal hypersensitivity (DH) with iontophoresis as a standalone treatment and in combination with commercially available toothpastes (Biomin and perfora) in the management of Dentinal hypersensitivity at baseline and 3 months: Randomized clinical study

Dr Vimarsha R Achar1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2025年10月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
27
试验地点
1
主要终点
Verbal rating scale

研究概览

简要总结

Dentinal hypersensitivity (DH) is characterized by brief, sharp pain from exposed dentin due to external stimuli, not linked to other dental issues. It often affects the cervical areas of premolars and canines, causing discomfort that can hinder proper oral hygiene. DH is triggered by thermal, chemical, and mechanical factors such as acidic foods, toothbrush abrasion, and cold stimuli.

Exposure of dentin can result from attrition, mastication, erosion, abfractions, gingival recession, and improper brushing. Treating DH involves occluding exposed dentinal tubules, achieved through various methods including physical and chemical tubule occlusion, nerve desensitization, and photo biomodulation.

Iontophoresis is a non-invasive technique using an electric field to enhance local and systemic drug delivery in dentistry, facilitating the penetration of drugs like fluoride and lidocaine into enamel, dentin, and oral tissues. This method leverages a low current to drive ionized drugs directly to targeted areas without systemic side effects.

Biomin, an inorganic biocompatible glass compound, contains calcium, fluoride, phosphate, and silica, promoting fluorapatite formation and effective dentinal tubule occlusion. Studies highlight its superior efficacy compared to other treatments for reducing DH. The market offers various options, including SLS-free toothpastes like perfora, which provide a gentler alternative for sensitive teeth.

This study aims to compare the effectiveness of iontophoresis alone and in combination with Biomin and perfora toothpastes in managing DH, focusing on their ability to alleviate symptoms and promote oral health.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients must have at least two sensitive permanent tooth surfaces on the buccal/facial aspects of incisors, canines, or premolars.
  • 2.Patients should be systemically healthy.
  • 3.Patients with wasting diseases and/or gingival recession will be included.
  • 4.must provide signed informed consent.
  • 5.Sensitive tooth surfaces should present with wasting diseases and/or gingival recession.

排除标准

  • 1.Patients who have undergone active periodontal treatment within the last 6 months.
  • 2.Pregnant or lactating females.
  • 3.Patients with deleterious habits such as smoking and/or alcohol consumption.
  • 4.Patients already undergoing treatment for dentinal hypersensitivity (DH).
  • 5.Patients with a known allergy.
  • 6.Patients with pacemakers.
  • 7.Patients with sensitivity due to gastroesophageal reflux disease (GERD).
  • 8.Patients with medical (including psychiatric and pharmacotherapeutic) histories that could compromise the study.
  • 9.Patients with systemic conditions that are etiologic or predisposing to dentinal hypersensitivity, including eating disorders.
  • 10.Patients who have received any dental treatment that might interfere with the action of the desensitizing agent being tested.
  • 11.Patients presenting with any other oral pathology.
  • 12.Individuals with orthodontic appliances or bridgework that could interfere with evaluation.
  • 13.Dentinal hypersensitivity will be assessed by air blast stimulation; patients unable to undergo this assessment will be excluded.

结局指标

主要结局

Verbal rating scale

时间窗: baseline | 2 weeks | 1 month | 3 months

Visual analogue scale

时间窗: baseline | 2 weeks | 1 month | 3 months

plaque index

时间窗: baseline | 2 weeks | 1 month | 3 months

次要结局

  • air blast test(tactile test)

研究者

发起方
Dr Vimarsha R Achar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vimarsha R Achar

Manipal College of Dental Sciences,Mangalore

研究点 (1)

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