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

Dentin Sensitivity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384044
• Other study ID #: 2015012
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: June 2019
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Device:
• Crest® Sensi-Stop™ Strips

• Colgate® Sensitivity Relief Pen

Locations

Country	Name	City	State
United States	Oral Health Science Center	Mason	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline for 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.	1 Day