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

August 29, 2011
November 14, 2011
September 2011
September 2011   (final data collection date for primary outcome measure)
  • Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use [ Time Frame: immediately after dentifrice use ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.
  • Tactile Hypersensitivity Score After 3 Days of Dentifrice Use [ Time Frame: 3 days after dentifrice use ] [ Designated as safety issue: No ]
    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.
  • Air Blast Hypersensitivity Score 3 Days After Dentifrice Use [ Time Frame: 3 days after dentifrice use ] [ Designated as safety issue: No ]

    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.
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 ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01426360 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Dentine Hypersensitivity
  • Other: control dentifrice
    use the dentifrice to brush teeth twice a day for one minute for 3 days
  • Other: strontium chloride/potassium nitrate dentifrice
    use the dentifrice to brush teeth twice daily for 3 days
  • Experimental: strontium chloride/potassium nitrate dentifrice
    Intervention: Other: strontium chloride/potassium nitrate dentifrice
  • Placebo Comparator: control dentifrice
    Intervention: Other: control dentifrice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01426360
DH-38
Yes
Liu Hongchun, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Hongchun Liu, Ph.D. Department of Preventive Dentistry,Guanghua College of Stomatology,Sun Yat-sen University
Sun Yat-sen University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP