A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

NCT03405259 | Completed Results FDA Device

• 1 other identifier: 2013077
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dentinal Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Super Seal® Desensitizer

EXPERIMENTAL

Professionally Applied

Device: Super Seal® Desensitizer

Acclean® Fluoride Varnish

SHAM COMPARATOR

Professionally Applied

Device: Acclean® Fluoride Varnish

Interventions

Super Seal® Desensitizer DEVICE

Single dose professional application.

Super Seal® Desensitizer

Acclean® Fluoride Varnish DEVICE

Single dose professional application.

Acclean® Fluoride Varnish

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: The Procter & Gamble Company

peters.j.2@pg.com

513-622-2489

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: June 26, 2013
• Primary Completion: September 13, 2013
• Study Completion: September 13, 2013
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-06