A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Procter and Gamble22 enrolled

Overview

The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dentinal Hypersensitivity

Interventions

Super Seal® DesensitizerDEVICE

Single dose professional application.

Acclean® Fluoride VarnishDEVICE

Single dose professional application.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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; * be in good general health as determined by the Investigator/designee; and * have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge. Exclusion Criteria: * allergy to rosin or to pine nuts; * self-reported pregnancy or nursing; * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; * active treatment for periodontitis; * fixed facial orthodontic appliances; * any diseases or conditions that might interfere with the safe completion of the study; or * an inability to undergo any study procedures.

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. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.

Time frame: Within 5 minutes after treatment was applied

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. A negative change from Baseline score represents a decrease in sensitivity from baseline.

Time frame: Within 5 minutes after treatment was applied

Data from ClinicalTrials.gov

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