A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

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 Overview

• Status: Completed
• Conditions: Dentinal Hypersensitivity
• Intervention / Treatment: Device: Super Seal® Desensitizer; Device: Acclean® Fluoride Varnish

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Super Seal® Desensitizer; Professionally Applied	Device: Super Seal® Desensitizer; Single dose professional application.
Sham Comparator: Acclean® Fluoride Varnish; Professionally Applied	Device: Acclean® Fluoride Varnish; Single dose professional application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Within 5 minutes after treatment was applied

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2013
• Primary Completion (Actual): September 13, 2013
• Study Completion (Actual): September 13, 2013

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: 2013077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes