A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Dentinal Hypersensitivity Clinical Trial

Official title:

A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405259
• Other study ID #: 2013077
• Status: Completed
• Phase: N/A
• Start date: June 26, 2013
• Est. completion date: September 13, 2013

Study information

• Verified date: June 2019
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 13, 2013
• Est. primary completion date: September 13, 2013
• 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;

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

• have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.

Exclusion Criteria:

• allergy to rosin or to pine nuts;

• self-reported pregnancy or nursing;

• severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;

• active treatment for periodontitis;

• fixed facial orthodontic appliances;

• 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

• Dentinal Hypersensitivity
• Hypersensitivity

Intervention

Device:
• Super Seal® Desensitizer
Single dose professional application.
• Acclean® Fluoride Varnish
Single dose professional application.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

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. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.	Within 5 minutes after treatment was applied
Primary	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. A negative change from Baseline score represents a decrease in sensitivity from baseline.	Within 5 minutes after treatment was applied