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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
Sponsor:
Information provided by (Responsible Party):
Patricia Hernández-Ríos, University of Chile

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : September 2016


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



Primary Outcome Measures :
  1. Differences in mean VAS score per subject [ Time Frame: Baseline, 4 and 8 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Patricia Hernández-Ríos, Professor +56229781839 phernandezrios@gmail.com
Contact: Johanna Contreras, Professor +56229781839 dra.j.contreras@gmail.com

Locations
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Chile
Faculty of Dentistry, University of Chile Recruiting
Santiago, Región Metropolitana, Chile
Contact: Patricia Hernández-Ríos, Professor    +56229781839    phernandezrios@gmail.com   
Sponsors and Collaborators
University of Chile

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Responsible Party: Patricia Hernández-Ríos, Professor, University of Chile
ClinicalTrials.gov Identifier: NCT02829879     History of Changes
Other Study ID Numbers: FIOUCh 13-103
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Patricia Hernández-Ríos, University of Chile:
Dentin Sensitivity
Arginin
Potassium Nitrate
Dentifrice
RCT

Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents