Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02829879

Enrollment

Registered

2016-07-12

Start date

2015-12-31

Completion date

Unknown

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Sensitivity

Keywords

Dentin Sensitivity, Arginin, Potassium Nitrate, Dentifrice, RCT

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.

Interventions

DRUG8% arginine/1450ppm sodium monofluorophosphate dentifrice

DRUG5% potassium nitrate/2500ppm sodium fluoride dentifrice

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Differences in mean VAS score per subject	Baseline, 4 and 8 weeks

Countries

Chile

Contacts

Primary ContactPatricia Hernández-Ríos, Professor

phernandezrios@gmail.com+56229781839

Backup ContactJohanna Contreras, Professor

dra.j.contreras@gmail.com+56229781839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026