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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

Tracking Information
First Submitted Date  ICMJE July 8, 2016
First Posted Date  ICMJE July 12, 2016
Last Update Posted Date July 12, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2016)
Differences in mean VAS score per subject [ Time Frame: Baseline, 4 and 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dentin Sensitivity
Intervention  ICMJE
  • Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice
  • Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice
Study Arms  ICMJE
  • Experimental: arginine
    25 volunteers with dentin sensitivity
    Intervention: Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice
  • Active Comparator: potassium nitrate
    25 volunteers with dentin sensitivity
    Intervention: Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 11, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02829879
Other Study ID Numbers  ICMJE FIOUCh 13-103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patricia Hernández-Ríos, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chile
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP