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Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

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Procter and Gamble

关键词

抽象

This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

日期

最后验证: 09/30/2019
首次提交: 07/13/2014
提交的预估入学人数: 07/13/2014
首次发布: 07/15/2014
上次提交的更新: 10/16/2019
最近更新发布: 11/04/2019
首次提交结果的日期: 08/29/2019
首次提交质量检查结果的日期: 10/16/2019
首次发布结果的日期: 11/04/2019
实际学习开始日期: 06/30/2014
预计主要完成日期: 08/31/2014
预计完成日期: 08/31/2014

状况或疾病

Dentin Sensitivity

干预/治疗

Device: Potassium oxalate

-

手臂组

干预/治疗
Experimental: potassium oxalate gel
Professional application
Active Comparator: Potassium oxalate liquid
Professional application

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- Provide written informed consent to participate in the study

- Be at least 18 years of age

- Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study

- Agree to refrain from participating in any other oral/dental product studies for the duration of the study

- Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study

- Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study

- Agree to comply with study/product usage instructions; and

- Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

- Gross oral neglect or urgent dental treatment needs

- Severe periodontal disease and/or generalized mobility

- Active treatment for periodontitis

- Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study

- Self-reported pregnancy or nursing

结果

主要结果指标

1. Change From Baseline Air Challenge [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.

次要成果指标

1. Change From Baseline Visual Analog Scale [30 Days]

Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.

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