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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 August 2016
Main ID:  NCT02829879
Date of registration: 08/07/2016
Prospective Registration: No
Primary sponsor: University of Chile
Public title: Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy
Scientific 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
Date of first enrolment: December 2015
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02829879
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Chile
Contacts
Name:     Patricia Hernández-Ríos, Professor
Address: 
Telephone: +56229781839
Email: phernandezrios@gmail.com
Affiliation: 
Name:     Patricia Hernández-Ríos, Professor
Address: 
Telephone: +56229781839
Email: phernandezrios@gmail.com
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Dentin Sensitivity
Intervention(s)
Drug: 5% potassium nitrate/2500ppm sodium fluoride dentifrice
Drug: 8% arginine/1450ppm sodium monofluorophosphate dentifrice
Primary Outcome(s)
Differences in mean VAS score per subject [Time Frame: Baseline, 4 and 8 weeks]
Secondary Outcome(s)
Secondary ID(s)
FIOUCh 13-103
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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