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临床试验/CTRI/2024/09/073401
CTRI/2024/09/073401尚未招募Phase 3 4

Efficacy of 10 percent Nanohydroxyapatite Paste as Desensitizer alone and in Combination with 940nm Diode Laser in Treatment of Dentin Hypersensitivity – A Split-Mouth Single Blind Clinical Trial.

SRM Dental College1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年9月25日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
23
试验地点
1
主要终点
Reduction of dentin hypersensitivity

研究概览

简要总结

Dentin hypersensitivity is conventionally defined as an episode of short sharp pain arising from exposed dentin after the application of thermal, tactile, chemical, osmotic, or evaporative stimuli, which cannot be caused by any other dental pathology and/or defect. The discomfort caused by dentinal hypersensitivity (DH) is one of the main challenges that dentists face in day to day clinical practice.

Dentin hypersensitivity presents an incidence of about 35% of the population worldwide and occurs mainly between 20 and 50 years of age.

Various treatment modalities exist in the form of desensitizing agents, restorations and laser.

Of the existing materials, no literature evidence of long term complete eradication of dentin hypersensitivity exists.

Recently, a bioactive material namely nano-hydroxyapatite is widely used in dentistry for tooth remineralization and in medicine as a bone substitute.Apart from being bio-compatible, nano-sized particles have similar morphology, structure and crystallinity compared with dental apatite.

Nanohydroxyapatite when applied on the surface of the dentin, it occludes the tubular openings  and  remineralizes the surface. This creates a dual action and the final end product being similar to the inorganic composition of the tooth. On the other hand over a period of time, the stability of the formed layer remains questionable due to wearing off the layer by external factors. Hence, in order to stabilize and to create an effective barrier, adjuvants has been recommended to be used along with desensitizing agent for management of dentin hypersensitivity.

One such is the use of laser.

Laser is been reported to play a noticeable role in treating hypersensitive dentin and providing consistent and repeated results by altering the surface by melting and resolidifying the surface and seals the exposed dentinal tubules by coagulation of proteins. However, direct irradiation of exposed dentin with laser would result in the propagation of the laser beam directly to the underlying pulpal tissue resulting in generation of heat causing undesirable effects on the tissues due to low absorption coefficients of diode lasers in dentin.

Hence to bring in the synergic effect and to overcome each individual drawback, combination of both 10% nanohydroxyapatite desensitizer and 940nm diode laser irradiation have been attempted. Though the literature evidence exists with this combination, the application protocol is standardized to only once. So this questions about the actual depth of penetration of the desensitizer into the dentinal tubules and its stability over a period of time. Hence this clinical study was undertaken to explore the effects of desensitizing agent by applying it for a continued period of time followed by application of laser for prolonged desensitizing effect.

As there are no previous literature reports on the detailed exploration of synergistic effect of 10% nanohydroxyapatite desensitizer followed by application of 940nm diode laser on long term efficacy for the treatment of dentin hypersensitivity, this present clinical study was undertaken  to  evaluate its  efficacy and longevity. The proposed null hypothesis is that there will be no reduction in postoperative sensitivity, immediately after treatment and at 14th day,1,3,6 and 9 months for the patients treated with the application of 10%  nanohydroxyapatite desensitizer and 940nm diode laser.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • Teeth with intact non-carious cervical lesions.
  • Teeth with gingival recession (Millers class 1 and 2).
  • Teeth with not more than 1.5 mm loss of dentin in depth which did not require restorative treatment.
  • Teeth with identical lesions bilaterally.

排除标准

  • Teeth with carious lesions.
  • Previously endodontically treated teeth.
  • Teeth with cracks, fractures, attrition, mobility, bruxism, gingival recession (Millers class 3 and 4) Unilateral loss of teeth.
  • Teeth with restorations for non-carious cervical lesions.
  • Recent desensitizer application.

结局指标

主要结局

Reduction of dentin hypersensitivity

时间窗: 14 days, 1,3,6 and 9 months

次要结局

  • Duration of desensitisation effect.(14 days, 1,3,6 and 9 months)

研究者

发起方
SRM Dental College
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Pravika P

SRM Institute of Science and Technology

研究点 (1)

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