A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

NCT02384044 | Completed Results

• 1 other identifier: 2015012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.

Conditions

Dentin Sensitivity

Keywords

Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Day

Secondary Outcomes (1)

• Change From Baseline for Air Challenge

  1 Day

Study Arms (2)

Crest® Sensi-Stop™ Strips

ACTIVE COMPARATOR

Professionally Applied

Device: Crest® Sensi-Stop™ Strips

Colgate® Sensitivity Relief Pen

ACTIVE COMPARATOR

Professionally Applied

Device: Colgate® Sensitivity Relief Pen

Interventions

Crest® Sensi-Stop™ Strips DEVICE

Crest® Sensi-Stop™ Strips

Colgate® Sensitivity Relief Pen DEVICE

Colgate® Sensitivity Relief Pen

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 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 25, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-06

Locations

US (1)