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临床试验/NCT07323693
NCT07323693已完成不适用

Clinical Efficacy of Using Bioactive Desensitizer Gel Versus Sodium Fluoride Varnish on Cervical Dentin Hypersensitivity in Adult Patients: A 6m Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Visual analog scale (VAS)

研究概览

简要总结

To evaluate and compare the clinical effectiveness of a Bioactive Desensitizer Gel (which releases calcium and phosphate to form hydroxyapatite) versus a standard 5% Sodium Fluoride (NaF) Varnish in reducing cervical dentin hypersensitivity (CDH) in adult patients over a period of 6 months.

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
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • With ≥1 sensitive tooth and with exposed dentin in the upper or lower dental arches.
  • Grade IV gingival recession.
  • Schiff sensitivity score needed to be ≥2, indicating that application of a jet of air makes the patient respond and move or requests discontinuation of the stimuli application.

排除标准

  • • Domestic or in-office fluoride application and bleaching 6 months before beginning of treatment
  • Long-term use of anti-inflammatory, analgesic and psychotropic drugs.
  • Allergies to product ingredients
  • Eating disorders, systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, gastroesophageal reflux disease, GERD)
  • Excessive dietary or environmental exposure to acids.
  • Orthodontic appliance treatment within the previous three months.
  • Periodontal surgery within the previous three months before the study

研究组 & 干预措施

Bioactive Desenstizer

Experimental

A micro-brush applicator was saturated with the material (Predicta Bioactive Desensitizer Gel) and massaged it into the tooth for 30-40 secs.Using a rubbing motion was used to liquefy the gel and allow it to penetrate the surface

干预措施: Treatment (Procedure)

sodium fluoride varnish

Active Comparator

干预措施: Treatment (Procedure)

结局指标

主要结局

Visual analog scale (VAS)

时间窗: Change from the Baseline, 1 week, 1 months, 3 months, 6 months

A VAS is a line that is 10 cm in length, the extremes of which represent the limits of pain, a patient may experience an external stimulus (The left endpoint designated no pain was marked as 0 and the right endpoint designated sever pain was marked as 10). Patients will be asked to place a mark on the 10 cm line that indicated their dentin hypersensitivity intensity

次要结局

  • Level of Pain Assessment using The Schiff sensitivity scale(Change from the Baseline, 1 week, 1 months, 3 months, 6 months)

研究者

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

Rawda Hesham Abd ElAziz

Associate Professor, Conservative dentistry department, Faculty of Dentistry, Cairo University

Cairo University

研究点 (1)

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