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

• ClinicalTrials.gov Identifier: NCT01426360
• Recruitment Status: Completed
• First Posted: August 31, 2011
• Results First Posted: December 19, 2011
• Last Update Posted: December 19, 2011
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Liu Hongchun, Sun Yat-sen University

Study Description

Brief Summary:

The objective of the present study was to compare the effects of a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base, versus a control dentifrice, containing exactly the same ingredients apart from strontium chloride and potassium nitrate, on the instant and lasting relief of DH.

Condition or disease	Intervention/treatment	Phase
Dentine Hypersensitivity	Other: control dentifrice; Other: strontium chloride/potassium nitrate dentifrice	Not Applicable

Detailed Description:

Dentin hypersensitivity (DH) is a very common complaint that occurs in the general population. The intensity of the pain can be minor to very serious, which may prevent one from eating or performing ordinary oral hygiene practices. The most accepted mechanism by which DH occurs is hydrodynamic theory, which suggests that pain-producing stimuli cause rapid movement of fluid within the dentin tubules, as a result the free nerve endings, at the inner ends of the tubules or the periphery of the pulp, are excited and DH occurs. According to this theory, one approach to treat DH is reducing dentin tubule fluid movement through occluding open tubules. Strontium chloride was the first tubule-blocking ingredient used in dentifrice about fifty years ago and since that time a paucity of clinical studies have been carried out to test its effectiveness on DH. The other approach is to reduce the pulp nerve excitability by depolarizing the nerve endings, in which the most widely used material is potassium salts. Although there is limited clinical evidence that dentifrices containing strontium chloride or potassium nitrate alone, as the major desensitizing agent, has an effect on reducing DH, no clinical studies have shown the effectiveness of a dentifrice containing both strontium chloride and potassium nitrate in a silica base on alleviating DH.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind Clinical Trial to Assess the Instant and Lasting Relief Effects of a Dentifrice Containing 2% Strontium Chloride and 5% Potassium Nitrate on Dentin Hypersensitivity
• Study Start Date: September 2011
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: strontium chloride/potassium nitrate dentifrice	Other: strontium chloride/potassium nitrate dentifrice; use the dentifrice to brush teeth twice daily for 3 days
Placebo Comparator: control dentifrice	Other: control dentifrice; use the dentifrice to brush teeth twice a day for one minute for 3 days

Outcome Measures

Primary Outcome Measures :

1. Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use [ Time Frame: 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.
2. Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use [ Time Frame: 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.
3. Tactile Hypersensitivity Score After 3 Days of Dentifrice Use [ Time Frame: 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.
4. Air Blast Hypersensitivity Score 3 Days After Dentifrice Use [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• good oral and general health
• possessing at least two teeth (incisors, cuspids, bicuspids and first molars with exposed cervical dentin) with hypersensitivity on facial surfaces which satisfied a tactile hypersensitivity stimulus score of 10-50 grams of force (Yeaple probe) and an air blast stimulus score of 2 or 3(Schiff Cold Air Scale)
• provided informed consent and were available for the study duration

Exclusion Criteria:

• progressive periodontitis, with teeth that had extensive restoration, suspected pulpitis, caries, cracked enamel or that were used as abutments for removable partial dentures,
• had hypersensitive teeth with a mobility greater than one
• had received periodontal treatment including surgery during the last year
• had used any other anti-hypersensitivity dentifrice or taken part in any other clinical trial, used any desensitizing agents during the last three months, or allergic to the ingredients of the dentifrices were excluded
• pregnant or breastfeeding women
• had taken the following drugs during the last month: anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs or daily analgesics

Contacts and Locations

Locations

China, Sichuan

the State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, China

Chengdu, Sichuan, China, 610041

Sponsors and Collaborators

Sun Yat-sen University

Investigators

• Principal Investigator: Hongchun Liu, Ph.D.; Department of Preventive Dentistry,Guanghua College of Stomatology,Sun Yat-sen University

More Information

Publications:

Fu Y, Li X, Que K, Wang M, Hu D, Mateo LR, DeVizio W, Zhang YP. Instant dentin hypersensitivity relief of a new desensitizing dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride: a 3-day clinical study in Chengdu, China. Am J Dent. 2010 May;23 Spec No A:20A-27A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Liu H, Hu D. Efficacy of a commercial dentifrice containing 2% strontium chloride and 5% potassium nitrate for dentin hypersensitivity: a 3-day clinical study in adults in China. Clin Ther. 2012 Mar;34(3):614-22. doi: 10.1016/j.clinthera.2012.01.027. Epub 2012 Mar 3.

• Responsible Party: Liu Hongchun, Ph.D, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01426360
• Other Study ID Numbers: DH-38
• First Posted: August 31, 2011
• Results First Posted: December 19, 2011
• Last Update Posted: December 19, 2011
• Last Verified: November 2011

Keywords provided by Liu Hongchun, Sun Yat-sen University:

dentifrice; potassium nitrate; strontium chloride

Additional relevant MeSH terms:

Dentin Sensitivity; Hypersensitivity; Immune System Diseases; Tooth Diseases; Stomatognathic Diseases