Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy
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|ClinicalTrials.gov Identifier: NCT02829879|
Recruitment Status : Unknown
Verified July 2016 by Patricia Hernández-Ríos, University of Chile.
Recruitment status was: Recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||December 2015|
|Estimated Primary Completion Date :||September 2016|
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
- Differences in mean VAS score per subject [ Time Frame: Baseline, 4 and 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829879
|Contact: Patricia Hernández-Ríos, Professorfirstname.lastname@example.org|
|Contact: Johanna Contreras, Professoremail@example.com|
|Faculty of Dentistry, University of Chile||Recruiting|
|Santiago, Región Metropolitana, Chile|
|Contact: Patricia Hernández-Ríos, Professor +56229781839 firstname.lastname@example.org|