Clinical Trial: Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Hyp
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.
Detailed Summary: 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.
Sponsor: Sun Yat-sen University
Current Primary Outcome:
- 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.
- 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;
- - Subject responds to air stimulus, but does not request discontinuation of stimulus;
- - Subject responds to air stimulus and requests discontinuation or moves from stimulus;
- - Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
- Tactile Hypersensitivity
Original Primary Outcome: Change from baseline in tactile and air blast hypersensitivity scores immediately after topical dentifrice use and 3 days after dentifrice use [ Time Frame: immediately after dentifrice use and 3 days after use ]
The subjects were instructed to apply the assigned dentifrice with a fingertip directly onto the hypersensitive teeth and massage each tooth for 1 minute. The subjects were provided with their assigned product and the same soft-bristled toothbrush for unsupervised tooth brushing for three days. Subjects were then re-evaluated immediately after topical dentifrice use and after 3 days of use, they received a thorough oral examination of their hard and soft tissues, followed by a careful evaluation of their tactile and air blast hypersensitivity scores using the Yeaple probe and the air syringe.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sun Yat-sen University
Dates:
Date Received: August 29, 2011
Date Started: September 2011
Date Completion:
Last Updated: November 14, 2011
Last Verified: November 2011
