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

• ClinicalTrials.gov Identifier: NCT02189382
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Results First Posted: August 20, 2018
• Last Update Posted: August 20, 2018
• Sponsor: Procter and Gamble
• Information provided by (Responsible Party): Procter and Gamble

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dentin Sensitivity	Device: Potassium Oxalate; Other: Water	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: June 2014
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Potassium Oxalate Gel; Self Applied	Device: Potassium Oxalate
Water; Self Applied	Other: Water

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline Air Challenge [ Time Frame: 30 days ]
   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.

Secondary Outcome Measures :

1. Change From Baseline in Tactile Threshold [ Time Frame: 30 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Nevada

Silverstone Research Group

Las Vegas, Nevada, United States, 89146

Sponsors and Collaborators

Procter and Gamble

More Information

• Responsible Party: Procter and Gamble
• ClinicalTrials.gov Identifier: NCT02189382
• Other Study ID Numbers: 2014029
• First Posted: July 14, 2014
• Results First Posted: August 20, 2018
• Last Update Posted: August 20, 2018
• Last Verified: July 2018

Keywords provided by Procter and Gamble:

Sensitivity

Additional relevant MeSH terms:

Dentin Sensitivity; Hypersensitivity; Immune System Diseases; Tooth Diseases; Stomatognathic Diseases