A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Not Applicable

Completed

• Conditions: Dentinal Hypersensitivity
• Interventions: Device: Acclean® Fluoride Varnish; Device: Super Seal® Desensitizer

• Registration Number: NCT03405259
• Lead Sponsor: Procter and Gamble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-26
• Primary Completion: 2013-09-13
• Study Completion: 2013-09-13
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-23
• Results First Submitted: 2019-04-26
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-14
• Last Update Submitted: 2019-06-14
• Results First Posted: 2019-06-17
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acclean® Fluoride Varnish	Acclean® Fluoride Varnish	Professionally Applied
Super Seal® Desensitizer	Super Seal® Desensitizer	Professionally Applied

Primary Outcome Measures

Name	Time	Method
Change From Baseline Air Challenge	Within 5 minutes after treatment was applied	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.
Change From Baseline Visual Analog Scale	Within 5 minutes after treatment was applied	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.