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临床试验/NCT06348849
NCT06348849已完成2 期

The Desensitising Effect of Nanosilver Fluoride Compared to Low-Level Laser Therapy in Molar-Incisor Hypomineralisation: A Randomised Controlled Clinical Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Desensitising effect in hypersensitive MIH molars

研究概览

简要总结

The aim of the current study is to assess the desensitising effect of nanosilver fluoride on first permanent molars (FPMs) in patients with MIH in comparison to low-level laser therapy.

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 (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The presence of at least one hypersensitive first permanent molar in MIH patient (using the Schiff Cold Air Sensitivity Scale (SCASS)).
  • Completion of an informed consent to participate in the study.

排除标准

  • Hypomineralised molars resulting from other medical conditions, such as enamel malformations associated with syndromes, dental fluorosis, enamel hypoplasia, amelogenesis imperfecta, and dental caries.
  • The presence of active tooth decay or defective restorations in the tooth under examination which can confound the aetiology of hypersensitivity with pulpitis.
  • The presence of pulpal symptoms.
  • Having undergone any professional desensitising treatment in the previous 6 months.
  • Having used a desensitising paste other than habitual toothpaste in the previous 3 months.
  • Use of anti-inflammatory drugs or analgesics at the time of recruitment.
  • Allergy or sensitivity to silver or any of the materials included in the study.

研究组 & 干预措施

Low-level laser therapy

Active Comparator

These hypersensitive molars with MIH will receive low-level laser therapy.

干预措施: Low-level laser therapy (Device)

Nanosilver fluoride

Experimental

These hypersensitive molars with MIH will receive nanosilver fluoride treatment.

干预措施: Nanosilver fluoride (Drug)

结局指标

主要结局

Desensitising effect in hypersensitive MIH molars

时间窗: 1 month

This will be performed using Schiff Cold Air Sensitivity Scale (SCASS). The SCASS will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus)

次要结局

  • Change in the plaque index scores(1 month)
  • Change in children's frequency of toothbrushing(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nouran Nabil

Instructor

Alexandria University

研究点 (1)

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