Trial Outcomes & Findings for Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity (NCT NCT01426360)

Results Overview

Immediately after dentifice use, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

immediately after dentifrice use

Results posted on

2011-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Strontium Chloride/Potassium Nitrate Dentifrice Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)	Control Dentifrice Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Overall Study STARTED	38	41
Overall Study COMPLETED	38	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Strontium Chloride/Potassium Nitrate Dentifrice n=38 Participants Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)	Control Dentifrice n=41 Participants Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants	41 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	42.37 years STANDARD_DEVIATION 8.8 • n=5 Participants	43.39 years STANDARD_DEVIATION 8.8 • n=7 Participants	42.9 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment China	38 participants n=5 Participants	41 participants n=7 Participants	79 participants n=5 Participants
Baseline tactile hypersensitivity score	12.63 gram STANDARD_DEVIATION 5.16 • n=5 Participants	12.2 gram STANDARD_DEVIATION 3.72 • n=7 Participants	12.41 gram STANDARD_DEVIATION 4.45 • n=5 Participants
Baseline air blast hypersensitivity score	2.42 Scores on a scale STANDARD_DEVIATION 0.41 • n=5 Participants	2.46 Scores on a scale STANDARD_DEVIATION 0.41 • n=7 Participants	2.44 Scores on a scale STANDARD_DEVIATION 0.41 • n=5 Participants

PRIMARY outcome

Timeframe: immediately after dentifrice use

Immediately after dentifice use, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.

Outcome measures

Outcome measures
Measure	Strontium Chloride/Potassium Nitrate Dentifrice n=38 Participants Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)	Control Dentifrice n=41 Participants Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use	19.47 gram Standard Deviation 14.69	14.27 gram Standard Deviation 5.76

PRIMARY outcome

Timeframe: immediately after dentifrice use

The tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at the exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects' response. 0 - Subject does not respond to air stimulus; 1. \- Subject responds to air stimulus, but does not request discontinuation of stimulus; 2. \- Subject responds to air stimulus and requests discontinuation or moves from stimulus; 3. \- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

Outcome measures

Outcome measures
Measure	Strontium Chloride/Potassium Nitrate Dentifrice n=38 Participants Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)	Control Dentifrice n=41 Participants Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use	1.93 scale Standard Deviation 0.51	2.22 scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: 3 days after dentifrice use

After 3 days, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified, reproducible force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.

Outcome measures

Outcome measures
Measure	Strontium Chloride/Potassium Nitrate Dentifrice n=38 Participants Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)	Control Dentifrice n=41 Participants Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Tactile Hypersensitivity Score After 3 Days of Dentifrice Use	19.87 gram Standard Deviation 14.95	14.27 gram Standard Deviation 5.98

PRIMARY outcome

Timeframe: 3 days after dentifrice use

After 3 days, tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects' response. 0 - Subject does not respond to air stimulus; 1. \- Subject responds to air stimulus, but does not request discontinuation of stimulus; 2. \- Subject responds to air stimulus and requests discontinuation or moves from stimulus; 3. \- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

Outcome measures

Outcome measures
Measure	Strontium Chloride/Potassium Nitrate Dentifrice n=38 Participants Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)	Control Dentifrice n=41 Participants Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Air Blast Hypersensitivity Score 3 Days After Dentifrice Use	1.8 scale Standard Deviation 0.56	2.13 scale Standard Deviation 0.6

Adverse Events

Strontium Chloride/Potassium Nitrate Dentifrice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Dentifrice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Liu Hongchun

Sun Yat-sen University

Phone: 86-0-13826189071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place