Dentine HypersensitivityNCT01426360
Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity
A study testing strontium chloride/potassium nitrate dentifrice in people with Dentine Hypersensitivity, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- strontium chloride/potassium nitrate dentifrice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, China
Chengdu, Sichuan, 610041
About this study
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
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.
Read the 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.
- Conditions
- Dentine Hypersensitivity
- Being tested
- control dentifrice, strontium chloride/potassium nitrate dentifrice
- Keywords
- dentifrice, potassium nitrate, strontium chloride
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control dentifriceOther
use the dentifrice to brush teeth twice a day for one minute for 3 days
strontium chloride/potassium nitrate dentifriceOther
use the dentifrice to brush teeth twice daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| strontium chloride/potassium nitrate dentifrice | Experimental | Not described Receives: Other: strontium chloride/potassium nitrate dentifrice |
| control dentifrice | Placebo comparator | Not described Receives: Other: control dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after dentifrice use
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;
- - 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.
Measured: immediately after dentifrice use
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.
Measured: 3 days after dentifrice use
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;
- - 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.
Measured: 3 days after dentifrice use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Hongchun, Sun Yat-sen University
- Investigators
- Hongchun Liu, Ph.D., Principal investigator, Department of Preventive Dentistry,Guanghua College of Stomatology,Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426360
- Sponsor's protocol ID
- DH-38
- Status last verified
- Nov 2011
- First submitted
- 29 Aug 2011
- Last updated
- 19 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 21284248Liu 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.
PubMed 22385928
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01426360
- Acronym / sponsor ID
- DH-38
- Conditions
- Dentine Hypersensitivity
- Keywords
- dentifrice, potassium nitrate, strontium chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 19 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strontium chloride/potassium nitrate dentifrice | Experimental | Other: strontium chloride/potassium nitrate dentifrice |
| control dentifrice | Placebo comparator | Other: control dentifrice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control dentifriceuse the dentifrice to brush teeth twice a day for one minute for 3 days | Other | control dentifrice |
| strontium chloride/potassium nitrate dentifriceuse the dentifrice to brush teeth twice daily for 3 days | Other | strontium chloride/potassium nitrate dentifrice |
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; 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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21284248Fu 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.
- Derived from this study: PubMed 22385928Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongchun Liu, Ph.D. principal investigator
Department of Preventive Dentistry,Guanghua College of Stomatology,Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strontium chloride/potassium nitrate dentifrice in people with Dentine Hypersensitivity, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use (time frame: immediately after dentifrice use). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426360, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.