Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

Dentin Sensitivity Clinical Trial

Official title:

A Clinical Study Comparing the Safety and Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Existing Dentinal Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152826
• Other study ID #: 2013145
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: August 2020
• 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 two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide written informed consent to participate in the study

• Be at least 18 years of age

• Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study

• Agree to refrain from participating in any other oral/dental product studies for the duration of the study

• Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study

• Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study

• Agree to comply with study/product usage instructions; and

• Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of = 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

• Gross oral neglect or urgent dental treatment needs

• Severe periodontal disease and/or generalized mobility

• Active treatment for periodontitis

• Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study

• Self-reported pregnancy or nursing

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Device:
• Potassium oxalate
Professional application

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

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 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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.	36 days
Secondary	Change From Baseline in Dentin Sensitivity	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.	36 days