Effectiveness of Two Water-Based Potassium Oxalate Desensitizers

N/ACompletedNCT02192307

Procter and Gamble60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dentin Sensitivity

Interventions

Potassium oxalateDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change From Baseline Air Challenge

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.

Time frame: 30 days

Secondary Outcomes

Change From Baseline Visual Analog Scale

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.

Time frame: 30 Days

Data from ClinicalTrials.gov

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