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临床试验/NCT03083496
NCT03083496Unknown不适用

Clinical Evaluation of Different Potassium Oxalate Concentrations in Dentin: A Randomized Clinical Trial

Federal University of Uberlandia1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年3月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
1
主要终点
Level of cervical dentin hypersensitivity by using visual analog scale

研究概览

简要总结

This study aims to evaluate the longevity and efficacy of two products potassium oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial (split-mouth) . The desensitization approach (single agent) and the long-term effectiveness (baseline, 1 week, 2 weeks, 3 weeks). Data will be collected, tabulated and submitted to statistical analysis.

详细描述

Dentin hypersensitivity (DH) is characterized as a short, intense and sudden pain caused by thermal, chemical and evaporative stimuli. There are several types of desensitizing agents, used to aid in the control of this pathology, but they are not very effective and have short longevity. The agents based on potassium oxalate have been used by dental surgeons because they have mixed action, both neural and obliterating. Therefore, the aim of this study is through a triple blind randomized clinical trial (split-mouth), evaluate the longevity and efficacy of two products potassium oxalate-based in two concentrations, 10% and 5%. Thirty-two with DH at least 2 teeth and adequate oral hygiene will be randomly divided into two different groups according to the desensitization approach (10% and 5%) The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2 and 3. Data will be collected, tabulated and submitted to statistical analysis.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals
  • Both genres, interested in the treatment of Dentin Hypersensitivity
  • Patients with all teeth in their mouth
  • Patients who have at least three teeth with Dentin hypersensitivity in different quadrants
  • Good oral hygiene

排除标准

  • Caries or unsatisfactory restorations
  • Presence of periodontal disease and or parafunctional habits
  • Cracks or enamel fractures
  • Extensive or unsatisfactory restorations
  • Recent restorations involving the labial surface
  • Orthodontics
  • Pregnant women
  • Gastroesophageal disease presence
  • Uncontrolled systemic disease
  • Severe bruxism
  • Constant use of analgesic
  • Allergic response to dental products

研究组 & 干预措施

Potassium Oxalate 5%

Active Comparator

Prophylaxis of the teeth; an application every 48 hours; 4 sessions

干预措施: Potassium Oxalate 5% (Drug)

Potassium Oxalate 5%

Active Comparator

Prophylaxis of the teeth; an application every 48 hours; 4 sessions

干预措施: Potassium Oxalate 10% (Drug)

Potassium Oxalate 10%

Active Comparator

Prophylaxis of the teeth; an application every 48 hours; 4 sessions

干预措施: Potassium Oxalate 5% (Drug)

Potassium Oxalate 10%

Active Comparator

Prophylaxis of the teeth; an application every 48 hours; 4 sessions

干预措施: Potassium Oxalate 10% (Drug)

结局指标

主要结局

Level of cervical dentin hypersensitivity by using visual analog scale

时间窗: 3 weeks

Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 3 weeks follow up.

次要结局

未报告次要终点

研究者

发起方
Federal University of Uberlandia
申办方类型
Other
责任方
Principal Investigator
主要研究者

PAULO VINICIUS SOARES

Professor

Federal University of Uberlandia

研究点 (1)

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