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临床试验/CTRI/2024/11/077272
CTRI/2024/11/077272尚未招募不适用

Comparative Clinical Evaluation of two In-office Desensitizing agents in Reducing Dentin hypersensitivity- A Randomised Split Mouth Clinical Trial

Dr Juttu Shirisha1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月20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
40
试验地点
1
主要终点
Efficacy of varnishes

研究概览

简要总结

Dentin hypersensitivity is a painful sensation commonly reported in daily practice.It is defined as a short, sharp pain that arises from exposed dentin in response to non-noxious stimuli, typically thermal, evaporative, tactile, osmotic or chemical, and that cannot be ascribed to any other form of dental defects or diseases.

The frequency of Dentin hypersensitivity increases with age; the majority of patients affected by Dentin hypersensitivity are between their second and fifth decades of life, with top events extending from 30 to 40 years of age. Females are more likely to be affected. The condition generally involves the facial surfaces of teeth at the cervical aspect and is very common in premolars and canines.

The treatments for dentin sensitivity include professional in-office, at-home or over-the-counter desensitizing agents.Application of desensitizing agents is the most frequently used non-invasive treatment for Dentin hypersensitivity, especially in cases with limited or invisible dental hard tissue loss or cervical exposure.The active compounds found in desensitization products could either block the openings of dentinal tubules thereby isolating the tubule contents or might directly desensitize the pulpal nerves.

In-office topical application of desensitizing agents used earlier worked by tubular occlusion. Nowadays, newer agents having remineralization properties and superior bond strength came into existence. Shield Force Plus (resin-based) and MI varnish (sodium fluoride-based) are such desensitizing agents.

Shield Force Plus, a one component self-etching light-cured dental adhesive based on Self Reinforcement technology, characterized by an Self Reinforcing monomer component that penetrates into the tooth substrate resulting in multi-point interactions with apatite calcium, and three-dimensional cross-linking reactions. It forms a thin, and uniform hard coating on the tooth surface for superior bond strength to the tooth substance.

MI varnish, which is used for in�’office treatment, acts by plugging the dentinal tubules and is a calcium phosphate�’based varnish. It is a 5% sodium fluoride�’based varnish with phosphopeptides (CPP) which stabilizes the amorphous calcium phosphate phase to deliver the bioavailable calcium, phosphate, and fluoride ions to the tooth surface to promote remineralization of the tooth structure.

The aim of this study is to assess the effectiveness of two in-office desensitizing agents in reducing dentinal hypersensitivity in patients with mild-to-moderate sensitivity with a 1-month follow-up.

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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients from 30 to 60 years of age with excellent systemic health conditions with history of dentin hypersensitivity with Preoperative Schiff scale of ≥1 and at least two or more lesions in two different quadrants of the mouth are included in this study.

排除标准

  • Patients who have used desensitizing toothpaste in the last 3 months, receiving periodontal therapy with cervical defects greater than 2mm horizontally, allergic to ingredients used in the study, chronic users of anti-inflammatory and analgesics, pregnant or nursing with uncontrolled systemic diseases, with fractured or cracked teeth are excluded from the study.

结局指标

主要结局

Efficacy of varnishes

时间窗: baseline score, immediately, after 1 week

次要结局

  • Efficacy of varnishes(after 1 month)

研究者

发起方
Dr Juttu Shirisha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Juttu Shirisha

Panineeya Institute of dental sciences and research centre

研究点 (1)

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