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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Liu Hongchun, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01426360
First received: August 29, 2011
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
Results First Received: October 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dentine Hypersensitivity
Interventions: Other: control dentifrice
Other: strontium chloride/potassium nitrate dentifrice

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    Strontium Chloride/Potassium Nitrate Dentifrice     Control Dentifrice  
STARTED     38     41  
COMPLETED     38     41  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
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)
Total Total of all reporting groups

Baseline Measures
    Strontium Chloride/Potassium Nitrate Dentifrice     Control Dentifrice     Total  
Number of Participants  
[units: participants]
 		  38     41     79  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     38     41     79  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.37  ± 8.8     43.39  ± 8.8     42.9  ± 8.7  
Gender  
[units: participants]
 		     
Female     27     28     55  
Male     11     13     24  
Region of Enrollment  
[units: participants]
 		     
China     38     41     79  
Baseline tactile hypersensitivity score [1]
[units: gram]
Mean ± Standard Deviation 		  12.63  ± 5.16     12.2  ± 3.72     12.41  ± 4.45  
Baseline air blast hypersensitivity score [2]
[units: Scores on a scale]
Mean ± Standard Deviation 		  2.42  ± 0.41     2.46  ± 0.41     2.44  ± 0.41  
[1] 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.
[2]

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
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1.  Primary:   Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use   [ Time Frame: immediately after dentifrice use ]
  Show Outcome Measure 1

2.  Primary:   Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use   [ Time Frame: immediately after dentifrice use ]
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3.  Primary:   Tactile Hypersensitivity Score After 3 Days of Dentifrice Use   [ Time Frame: 3 days after dentifrice use ]
  Show Outcome Measure 3

4.  Primary:   Air Blast Hypersensitivity Score 3 Days After Dentifrice Use   [ Time Frame: 3 days after dentifrice use ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Liu Hongchun
Organization: Sun Yat-sen University
phone: 86-0-13826189071
e-mail: hongchun751@sina.com


Publications:

Publications automatically indexed to this study:


Responsible Party: Liu Hongchun, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01426360     History of Changes
Other Study ID Numbers: DH-38
Study First Received: August 29, 2011
Results First Received: October 1, 2011
Last Updated: November 14, 2011
Health Authority: China: Ministry of Health