A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity

NCT02293044 | Completed Results

• 1 other identifier: 2014115
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.

Conditions

Dentin Sensitivity

Keywords

Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Cold Water Challenge

  The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water 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.

  1 Day

Secondary Outcomes (1)

• Change From Baseline Visual Analog Scale

  1 Day

Study Arms (1)

Crest® Sensi-Stop™ Strips

EXPERIMENTAL

Self 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
• have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale in response to the 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
• self-reported pregnancy or nursing
• a history of kidney stones
• 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: November 7, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 25, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-06

Locations

US (1)