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

Dentin Sensitivity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189382
• Other study ID #: 2014029
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2018
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Device:
• Potassium Oxalate

Other:
• Water

Locations

Country	Name	City	State
United States	Silverstone Research Group	Las Vegas	Nevada

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 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	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