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Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

Primary Purpose

Dentin Sensitivity

Status
Unknown status
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
8% arginine/1450ppm sodium monofluorophosphate dentifrice
5% potassium nitrate/2500ppm sodium fluoride dentifrice
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Dentin Sensitivity, Arginin, Potassium Nitrate, Dentifrice, RCT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Dentistry, University of ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

arginine

potassium nitrate

Arm Description

25 volunteers with dentin sensitivity

25 volunteers with dentin sensitivity

Outcomes

Primary Outcome Measures

Differences in mean VAS score per subject

Secondary Outcome Measures

Full Information

First Posted
July 8, 2016
Last Updated
July 11, 2016
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02829879
Brief Title
Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Dentin Sensitivity, Arginin, Potassium Nitrate, Dentifrice, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
arginine
Arm Type
Experimental
Arm Description
25 volunteers with dentin sensitivity
Arm Title
potassium nitrate
Arm Type
Active Comparator
Arm Description
25 volunteers with dentin sensitivity
Intervention Type
Drug
Intervention Name(s)
8% arginine/1450ppm sodium monofluorophosphate dentifrice
Intervention Type
Drug
Intervention Name(s)
5% potassium nitrate/2500ppm sodium fluoride dentifrice
Primary Outcome Measure Information:
Title
Differences in mean VAS score per subject
Time Frame
Baseline, 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Hernández-Ríos, Professor
Phone
+56229781839
Email
phernandezrios@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Contreras, Professor
Phone
+56229781839
Email
dra.j.contreras@gmail.com
Facility Information:
Facility Name
Faculty of Dentistry, University of Chile
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Hernández-Ríos, Professor
Phone
+56229781839
Email
phernandezrios@gmail.com

12. IPD Sharing Statement

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Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

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