Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis

Dentin Sensitivity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481557
• Other study ID #: 2015069
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2015

Study information

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

Clinical Trial Summary

This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2015
• Est. primary completion date: June 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

• sign an informed consent form and be given a copy

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

• agree to delay any elective dentistry, and to report any dentistry received during the course of the study

• agree to not participate in any other oral care study for the duration of this study

• agree to return for scheduled visits and follow all study procedures

• 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:

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

• active treatment for periodontitis

• any diseases or conditions that might interfere with the subject safely completing the study

• inability to undergo study procedures

• fixed orthodontic appliances

Related Conditions & MeSH terms

• Dentin Sensitivity

Intervention

Device:
• Oxalate Salt Solution
Applied by dentist

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.	10 Minutes
Primary	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.	Baseline
Secondary	Change From Baseline for Yeaple Probe	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.	10 Minutes
Secondary	Baseline 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.	Baseline