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临床试验/CTRI/2024/01/061959
CTRI/2024/01/061959招募中3 期

Effectiveness of Calcium Sodium Phosphosilicate based Desensitising Paste with Diode Laser Compared to Diode Laser Alone in the Management of Dentin Hypersensitivity- A Randomized Clinical Trial.

LSai Sindhuja1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月2日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
visual analogue scale(VAS) score

研究概览

简要总结

Dentin hypersensitivity(DH) has been defined as short, sharp pain arising from exposed dentin as a result of various stimuli, such as heat, cold,chemical or osmotic, which cannot be ascribed to any other form of dental defect or pathology(Holland et al 1997).Its often referred as “common cold of dentistry†due to its high prevalence which ranges from 2.8% to 74%. But most treatments available till date doesn’t give immediate relief and are effective only for a short while. An inorganic amorphous calcium and sodium phosphosilicate belonging to the group of materials known as bioactive glass is commercially available with the brand name Novamin is commonly prescribed by the dentists to the patients suffering from DH. Laser desensitization is also an efficient alternative for the immediate treatment of hypersensitivity. So this study is to compare the effect of application of calcium sodium phosphosilicate ( CSPS )bioactive glass with diode laser and diode laser alone in the management of dentin hypersensitivity as measured by visual analogue scale ( VAS ) score using the evaluation tests immediately after treatment, at 1st month and at 6th month and to asess the best treatment outcome. The study design is double blinded randomized clinical trial where the patients and the outcome asessor will be blinded. Patients reporting to the out patient clinic in the Dept of Conservative Dentistry & Endodontics complaining about dentin hypersensitivity, who satisfies inclusion and exclusion criteria will be selected as subjects. The subjects will be allocated into two different groups randomly and the treatment will be given to each group respectively. In the treatment A group diode laser treatment is given alone. In the other treatment arm B group combined diode laser and bioactive glass treatment will be given. The subjects will be asked to score the elicitated pain based on the VAS. The VAS scoring will be done before the start of the treatment, immediately after the treatment, again at 1st month and at 6th month. Results will be drawn at the end of the study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients between 20-45 years of age
  • Patients with minimum of two hypersensitive teeth.
  • Defects <1mm loss of dentin in depth which did not require restorative treatment.
  • Preoperative VAS score ≥ 2
  • Willing to give informed consent.

排除标准

  • 1.Teeth with caries, defective restorations, occlusal restorations, chipped teeth.
  • Deep periodontal pockets, periodontal surgery within 3 months, and subjects with orthodontic appliance or bridge work.
  • Use of desensitizing paste in the last 3 month.
  • Any gross oral pathology.
  • Subject on analgesics
  • Uncontrolled systemic disease.
  • Persons with mental health issues.
  • Pregnant or lactating females.
  • 9.Patients undergone bleaching.

结局指标

主要结局

visual analogue scale(VAS) score

时间窗: Before and immediately after the treatment, again at 1st and at 6th month

次要结局

  • Reduction of pain assessment using visual analogue scale score(Before and immediately after the treatment, again at 1st and at 6th month)

研究者

发起方
LSai Sindhuja
申办方类型
Other [Dr. L.Sai Sindhuja (self)]

研究点 (1)

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