A Pilot Study to Assess Nominal Versus Controlled Stimuli on Dentinal Hypersensitivity

NCT02406573 | Completed Results

• 1 other identifier: 2015024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity response relative to a clinically-controlled stimulus.

Conditions

Dentin Sensitivity

Keywords

Sensitivity

Outcome Measures

Primary Outcomes (3)

• Change From Baseline for Visual Analog Scale - Cold Water

  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.

  Day 1

• Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index

  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.

  Day 1

• Change From Baseline for 5 Face Emoticon Scale

  Scale to score their comfort/discomfort that ranges from -2 to +2 where a -2 is considered very comfortable and a +2 is considered very uncomfortable.

  Day 2

Study Arms (1)

Crest® Sensi-Stop™ Strips

EXPERIMENTAL

Professionally Applied

Device: Crest® Sensi-Stop™ Strips

Interventions

Crest® Sensi-Stop™ Strips DEVICE

Crest® Sensi-Stop™ Strips

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
• sign an informed consent form and be given a copy
• be in good general health as determined by the Investigator/designee
• agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study
• agree to not participate in any other oral care study for the duration of this study
• agree to return for scheduled visits and follow all study procedures
• have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the examiner applied cold water challenge

You may not qualify if:

• severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
• active treatment for periodontitis
• any diseases or conditions that might interfere with the subject safely completing the study
• inability to undergo study procedures
• fixed facial orthodontic appliances
• a history of kidney stones
• self-reported pregnancy or nursing
• known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Oral Health Science Center

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Results Point of Contact

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

peters.j.2@pg.com

513-622-2489

Study Officials

• Robert W Gerlach, DDS, MPH

  Procter and Gamble

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (1)