Dentine Hypersensitivity
Conditions
Keywords
dentifrice, potassium nitrate, strontium chloride
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 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.
Interventions
OTHERcontrol dentifrice
use the dentifrice to brush teeth twice a day for one minute for 3 days
OTHERstrontium chloride/potassium nitrate dentifrice
use the dentifrice to brush teeth twice daily for 3 days
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use | 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 | 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. |
| Tactile Hypersensitivity Score After 3 Days of Dentifrice Use | 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. |
| Air Blast Hypersensitivity Score 3 Days After Dentifrice Use | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 38 |
| 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) | 41 |
| Total | 79 |
Baseline characteristics
| Characteristic | Strontium Chloride/Potassium Nitrate Dentifrice | Control Dentifrice | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 41 Participants | 79 Participants |
| Age Continuous | 42.37 years STANDARD_DEVIATION 8.8 | 43.39 years STANDARD_DEVIATION 8.8 | 42.9 years STANDARD_DEVIATION 8.7 |
| Baseline air blast hypersensitivity score | 2.42 Scores on a scale STANDARD_DEVIATION 0.41 | 2.46 Scores on a scale STANDARD_DEVIATION 0.41 | 2.44 Scores on a scale STANDARD_DEVIATION 0.41 |
| Baseline tactile hypersensitivity score | 12.63 gram STANDARD_DEVIATION 5.16 | 12.2 gram STANDARD_DEVIATION 3.72 | 12.41 gram STANDARD_DEVIATION 4.45 |
| Region of Enrollment China | 38 participants | 41 participants | 79 participants |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 41 |
| serious Total, serious adverse events | 0 / 38 | 0 / 41 |
Outcome results
Primary
Air Blast Hypersensitivity Score 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.
Time frame: 3 days after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strontium Chloride/Potassium Nitrate Dentifrice | Air Blast Hypersensitivity Score 3 Days After Dentifrice Use | 1.8 scale | Standard Deviation 0.56 |
| Control Dentifrice | Air Blast Hypersensitivity Score 3 Days After Dentifrice Use | 2.13 scale | Standard Deviation 0.6 |
Primary
Air Blast Hypersensitivity Scores Immediately After Topical 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.
Time frame: immediately after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strontium Chloride/Potassium Nitrate Dentifrice | Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use | 1.93 scale | Standard Deviation 0.51 |
| Control Dentifrice | Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use | 2.22 scale | Standard Deviation 0.6 |
Primary
Tactile Hypersensitivity Score After 3 Days of 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.
Time frame: 3 days after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strontium Chloride/Potassium Nitrate Dentifrice | Tactile Hypersensitivity Score After 3 Days of Dentifrice Use | 19.87 gram | Standard Deviation 14.95 |
| Control Dentifrice | Tactile Hypersensitivity Score After 3 Days of Dentifrice Use | 14.27 gram | Standard Deviation 5.98 |
Primary
Tactile Hypersensitivity Scores Immediately After Topical 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.
Time frame: immediately after dentifrice use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strontium Chloride/Potassium Nitrate Dentifrice | Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use | 19.47 gram | Standard Deviation 14.69 |
| Control Dentifrice | Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use | 14.27 gram | Standard Deviation 5.76 |