A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes

Dentin Sensitivity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513212
• Other study ID #: 2015059
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2015

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 determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2015
• Est. primary completion date: September 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;

• provide written informed consent prior to participation and be given a signed copy of the informed consent form;

• complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;

• be in good general health as determined by the Investigator/designee; and

• have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air 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;

• 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
Professionally applied liquid

Drug:
• Stannous fluoride paste
SnF2 Paste

Device:
• Manual toothbrush
Marketed manual toothbrush
• Power toothbrush
Marketed power toothbrush

Locations

Country	Name	City	State
United States	Chad J Anderson DMD Inc	Fresno	California

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 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.	30 days