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临床试验/NCT06025084
NCT06025084已完成1 期

The Effect of Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles on The Permeability of Dentinal Tubules After Exposure to Wear Challenges and Their Clinical Efficacy in The Treatment of Dentin Hypersensitivity

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Assessment of dentin hypersensitivity

研究概览

简要总结

Dentin hypersensitivity is one of the most commonly occurring clinical dental conditions which is characterized by short and sharp pain which arises from exposed dentin in response to external stimuli, which typically are thermal, evaporative, tactile, osmotic or chemical.

Hypersensitive dentin is mostly found in buccal tooth areas, in which enamel is missing because of abrasion, attrition, or erosion. The most generally accepted theory regarding the mechanism of dentin hypersensitivity is the hydrodynamic theory. It proposes that a pain-provoking stimulus increases the flow of the dentinal tubular fluid and consequently, stimulates the nerves around the odontoblasts, leading to dentin hypersensitivity.

详细描述

Dentin desensitizing products, containing agents such as fluoride, strontium salts, oxalate, glutaraldehyde and bioactive glass, are employed to treat dentin hypersensitivity.

Based on the hydrodynamic theory, there are two main strategies for the treatment of dentin hypersensitivity as: (1) occluding the dentinal tubules to reduce the fluid flow, and (2) decreasing the excitability of the intradental nerve.

Although these products and agents were reported to be effective, short durability and poor effectiveness were often exhibited. The therapeutic effects of these desensitizing products were short lived on account of daily tooth brushing or drinking of acidic beverages and the occlusion effects were sometimes incomplete. Owing to these drawbacks, the use of nanomaterials as dentin occluding material has been predicted to be the future of treating DH.

Amorphous Calcium Phosphate (ACP) has the potential to remineralize the structure of tooth. ACP is a soluble calcium phosphate compound that discharges calcium and phosphate ions to change to apatite and remineralize the tooth structure when it comes in contact with saliva. Forming on the enamel and within the dental tubules, ACP provides a reservoir of phosphate and calcium ions in the saliva Casein phospho-peptide (CPP) is a milk-derived protein that joins to the tooth's biofilm and is applied to stabilize ACP. In recent years, remineralization products used CPP as a vehicle to deliver and preserve a super saturation state of ACP near the surface of tooth. A previous study showed that the application of (CPP-ACP) containing agents as GC tooth mousse and MI paste plus can reduce dentin permeability by occluding dentin tubules. It revealed that these materials can be effective for treatment of dentin hypersensitivity.

Recently, there has been a renewed interest in developing materials with a bioactive potential that could block the exposed dentinal tubules and subsequently reduce the fluid flow within the tubules. Eggshells (EBs) have been investigated in recent years for their remineralization capabilities. EB has rich bioavailable calcium content in the form of carbonates and oxides. It contains 94% calcium carbonate, 1% calcium phosphate, 1% magnesium carbonate, and 4% organic matter. In addition, eggshell provides a cost-effective, renewable, and sustainable source of material for EnHAp. A previous study revealed that eggshell powder is predicted to be the future of tooth remineralization and highly effective in occluding dentinal tubules and reducing dentin hypersensitivity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1- For patients;
  • Age between 20 and 55 years
  • Patients in good systemic health with clinically elicitable dentin hypersensitivity
  • Absence of contraindications to the proposed therapies as allergy. 2 - For teeth;
  • Absence of local pathologies (e.g., caries and fractures)
  • Visual analog scale (VAS) score ≥3

排除标准

  • -- For patients;
  • Use of any desensitizing toothpaste for previous 3 or 4 months.
  • Taking analgesics/anti-inflammatory drugs at the time of the study, pregnancy, and smoking.
  • 2 -For teeth ;
  • Teeth with abrasion and attrition.
  • Carious lesions on the selected or neighboring teeth, defective restorations
  • Any professional desensitizing therapy on the selected teeth during the last 6 months.

研究组 & 干预措施

first group (A1)

Active Comparator

About 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles

干预措施: Egg Shell nanoparticles (Drug)

second group (A2)

Active Comparator

About 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2.

干预措施: Egg Shell nanoparticles (Drug)

结局指标

主要结局

Assessment of dentin hypersensitivity

时间窗: from baseline to 2 months after the treatment day.

The pain response will be assessed using the numerical Visual Analogue Scale (VAS, range 0-10), with 0 indicating 'no pain' and 10 indicating 'intolerably severe pain.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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