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

NCT01426360 | Completed Results DMC

• 1 other identifier: DH-38
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentine Hypersensitivity

Keywords

dentifrice; potassium nitrate; strontium chloride

Outcome Measures

Primary Outcomes (4)

• 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.

  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; 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.

  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.

  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; 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.

  3 days after dentifrice use

Study Arms (2)

strontium chloride/potassium nitrate dentifrice

EXPERIMENTAL

Other: strontium chloride/potassium nitrate dentifrice

control dentifrice

PLACEBO COMPARATOR

Other: control dentifrice

Interventions

control dentifrice OTHER

use the dentifrice to brush teeth twice a day for one minute for 3 days

control dentifrice

strontium chloride/potassium nitrate dentifrice OTHER

use the dentifrice to brush teeth twice daily for 3 days

strontium chloride/potassium nitrate dentifrice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Chengdu, Sichuan, 610041, China

Location

Related Publications (2)

• 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.

  PMID: 21284248 BACKGROUND

• 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.

  PMID: 22385928 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

strontium chloride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Liu Hongchun
• Organization: Sun Yat-sen University

hongchun751@sina.com

86-0-13826189071

Study Officials

• Hongchun Liu, Ph.D.

  Department of Preventive Dentistry,Guanghua College of Stomatology,Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 31, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 19, 2011
• Results First Posted: December 19, 2011

Record last verified: 2011-11

Locations

CN (1)