Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

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Вход / Регистрация

Линкът е запазен в клипборда

СъстояниеЗавършен

Спонсори

Procter and Gamble

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT02192307

BioSeek: nct02192307

Ключови думи

Резюме

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

Дати

Последна проверка:	09/30/2019
Първо изпратено:	07/13/2014
Очаквано записване подадено:	07/13/2014
Първо публикувано:	07/15/2014
Изпратена последна актуализация:	10/16/2019
Последна актуализация публикувана:	11/04/2019
Дата на първите подадени резултати:	08/29/2019
Дата на първите подадени резултати от QC:	10/16/2019
Дата на първите публикувани резултати:	11/04/2019
Действителна начална дата на проучването:	06/30/2014
Приблизителна дата на първично завършване:	08/31/2014
Очаквана дата на завършване на проучването:	08/31/2014

Състояние или заболяване

Dentin Sensitivity

Интервенция / лечение

Device: Potassium oxalate

Фаза

Групи за ръце

Arm	Интервенция / лечение
Experimental: potassium oxalate gel Professional application
Active Comparator: Potassium oxalate liquid Professional application

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Приема здрави доброволци	Да
Критерии	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

Резултат

Първични изходни мерки

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.

Вторични изходни мерки

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.

Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

Ключови думи

oxalate

калий

potassium oxalate

hypersensitivity