Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Other: Water; Device: Potassium Oxalate

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Silverstone Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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;
• complete a confidentiality disclosure agreement;
• be in good general health as determined by the Investigator/designee;
• agree not to participate in any other oral/dental product studies during the course of this study;
• agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
• agree to refrain from the use of any non-study oral hygiene products;
• agree to return for all scheduled visits and follow study procedures; and.
• have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge

Exclusion Criteria:

• self-reported pregnancy or nursing;
• severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
• active treatment of periodontitis;
• fixed facial orthodontic appliances;
• 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
• any diseases or conditions that might interfere with the safe completion of the study; or
• an inability to undergo any study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Potassium Oxalate Gel; Self Applied	Device: Potassium Oxalate
Other: Water; Self Applied	Other: Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Tactile Threshold	Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.	30 days

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Sensitivity
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: 2014029