跳至主要内容
临床试验/NCT02513212
NCT02513212已完成不适用

A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes

Procter and Gamble1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Change From Baseline Air Challenge

研究概览

简要总结

This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • be at least 18 years of age;
  • provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
  • be in good general health as determined by the Investigator/designee; and
  • have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air challenge.

排除标准

  • self-reported pregnancy or nursing;
  • severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
  • active treatment of periodontitis;
  • any diseases or conditions that might interfere with the safe completion of the study; or
  • an inability to undergo any study procedures.

研究组 & 干预措施

oxalate liquid, SnF2 paste, manual toothbrush

Other

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush

干预措施: Potassium Oxalate (Device)

oxalate liquid, SnF2 paste, manual toothbrush

Other

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush

干预措施: Stannous fluoride paste (Drug)

oxalate liquid, SnF2 paste, manual toothbrush

Other

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush

干预措施: Manual toothbrush (Device)

oxalate liquid, SnF2 paste, power toothbrush

Other

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush

干预措施: Potassium Oxalate (Device)

oxalate liquid, SnF2 paste, power toothbrush

Other

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush

干预措施: Stannous fluoride paste (Drug)

oxalate liquid, SnF2 paste, power toothbrush

Other

Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush

干预措施: Power toothbrush (Device)

结局指标

主要结局

Change From Baseline Air Challenge

时间窗: 30 days

The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.

次要结局

  • Change From Baseline Visual Analog Scale(30 days)

研究者

发起方
Procter and Gamble
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验