Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

Sponsor

University of Chile (Other)

Overall Status

Unknown status

CT.gov ID

NCT02829879

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dentin Sensitivity	Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of the Clinical Effectiveness of 8% Arginine/1450 Ppm Sodium Monofluorophosphate Versus 5% Potassium Nitrate/2500 Ppm Sodium Fluoride in Dentin Hypersensitivity Therapy: A Randomized Controlled Clinical Trial

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: arginine 25 volunteers with dentin sensitivity	Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice
Active Comparator: potassium nitrate 25 volunteers with dentin sensitivity	Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice

Arm

Intervention/Treatment

Experimental: arginine

25 volunteers with dentin sensitivity

Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice

Active Comparator: potassium nitrate

25 volunteers with dentin sensitivity

Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice

Outcome Measures

Primary Outcome Measures

Differences in mean VAS score per subject [Baseline, 4 and 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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