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

NCT ID: NCT01426360

Last Updated: 2011-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Dentine Hypersensitivity

Keywords

dentifrice; potassium nitrate; strontium chloride

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

strontium chloride/potassium nitrate dentifrice

Group Type: EXPERIMENTAL

strontium chloride/potassium nitrate dentifrice

Intervention Type: OTHER

use the dentifrice to brush teeth twice daily for 3 days

control dentifrice

Group Type: PLACEBO_COMPARATOR

control dentifrice

Intervention Type: OTHER

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

Interventions

control dentifrice

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

Intervention Type: OTHER

strontium chloride/potassium nitrate dentifrice

use the dentifrice to brush teeth twice daily for 3 days

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Liu Hongchun

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongchun Liu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 21284248 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22385928 (View on PubMed)

Other Identifiers

DH-38

Identifier Type: -

Identifier Source: org_study_id