Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Brief Summary

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Introduction: Dentin hypersensitivity (DH) could be defined as a brief and sharp pain in response to thermical, chemical, tactile and osmotic stimuli, which cannot be attributed to any dental condition or pathology. Multiple therapies for the treatment of DH have been studied, including equivocal evidence about the efficacy of potassium nitrate salts and recent investigations a promising new 8% Arginin dentifrice.

Aim: The aim of this study is to compare the clinical effectiveness of 8% arginine/1450ppm sodium monofluorophosphate (D1) and 5% potassium nitrate/2500ppm sodium fluoride (D2) dentifrices in the treatment of dentin hypersensitivity.

Methods: Parallel-design, double-masked, randomized controlled clinical trial. Fifty healthy volunteers aged 18 to 70 years who attend at the Faculty of Dentistry , University of Chile, with DH and a visual analog scale (VAS) score ≥4 at least in two anterior and/or premolar teeth, will be selected and randomized into two treatment groups: T1 (n=25): 8% arginine/1450 ppm sodium monofluorophosphate dentifrice (D1); and T2 (n=25): 5% potassium nitrate/2500 ppm sodium fluoride dentifrice (D2). Environmental, dietary and oral hygiene habits will be recorded in a clinical chart, while O´Leary plaque index and dentin hypersensitivity (DH) measurements will be clinically assessed, at baseline, 4 and 8 weeks. DH will be evaluated through the mean VAS value in response to evaporative and thermal stimuli at baseline, 4 and 8 week follow-up. The data will be analysed through Stata® V11 program.

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Detailed Description

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Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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arginine

25 volunteers with dentin sensitivity

Group Type EXPERIMENTAL

8% arginine/1450ppm sodium monofluorophosphate dentifrice

Intervention Type DRUG

potassium nitrate

25 volunteers with dentin sensitivity

Group Type ACTIVE_COMPARATOR

5% potassium nitrate/2500ppm sodium fluoride dentifrice

Intervention Type DRUG

Interventions

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8% arginine/1450ppm sodium monofluorophosphate dentifrice

Intervention Type DRUG

5% potassium nitrate/2500ppm sodium fluoride dentifrice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 70 years
* Dentin sensitivity in at least 2 teeth (incisors, cuspids and/or bicuspids) with a VAS score ≥4
* Good general health

Exclusion Criteria

* Defective or extensive restorations, deep dental caries, pulpitis, chipped teeth,
* Bridgework, dentures or crowned teeth that could interfere with the evaluation of hypersensitivity
* Pregnancy or lactation
* Ongoing treatment with anti-inflammatory or sedative drugs
* Systemic conditions that are etiologic or predisposing to dentine hypersensitivity, like chronic acid regurgitation
* Ongoing periodontal therapy or periodontal surgery in the preceding 3 months
* Allergic responses to the dentifrices
* Hypersensitivity treatment in the preceding 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No