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

Primary Purpose

Dentine Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
control dentifrice
strontium chloride/potassium nitrate dentifrice
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentine Hypersensitivity focused on measuring dentifrice, potassium nitrate, strontium chloride

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

strontium chloride/potassium nitrate dentifrice

control dentifrice

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2011
Last Updated
November 14, 2011
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01426360
Brief Title
Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Hypersensitivity
Keywords
dentifrice, potassium nitrate, strontium chloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strontium chloride/potassium nitrate dentifrice
Arm Type
Experimental
Arm Title
control dentifrice
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
control dentifrice
Intervention Description
use the dentifrice to brush teeth twice a day for one minute for 3 days
Intervention Type
Other
Intervention Name(s)
strontium chloride/potassium nitrate dentifrice
Intervention Description
use the dentifrice to brush teeth twice daily for 3 days
Primary Outcome Measure Information:
Title
Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use
Description
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
Title
Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use
Description
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.
Time Frame
immediately after dentifrice use
Title
Tactile Hypersensitivity Score After 3 Days of Dentifrice Use
Description
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
Title
Air Blast Hypersensitivity Score 3 Days After Dentifrice Use
Description
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.
Time Frame
3 days after dentifrice use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongchun Liu, Ph.D.
Organizational Affiliation
Department of Preventive Dentistry,Guanghua College of Stomatology,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21284248
Citation
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.
Results Reference
background
PubMed Identifier
22385928
Citation
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.
Results Reference
derived

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

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