Effectiveness of Arginin and Potassium Nitrate Dentifrices in Dentin Hypersensitivity Therapy

Dentin Sensitivity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02829879
• Other study ID #: FIOUCh 13-103
• Status: Recruiting
• Phase: Phase 3
• First received: July 8, 2016
• Last updated: July 11, 2016
• Start date: December 2015

Study information

• Verified date: July 2016
• Source: University of Chile
• Contact: Patricia Hernández-Ríos, Professor
• Phone: +56229781839
• Email: phernandezrios[@]gmail.com
• Is FDA regulated: No
• Health authority: Chile: Faculty of Dentistry, University of Chile
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• 8% arginine/1450ppm sodium monofluorophosphate dentifrice

• 5% potassium nitrate/2500ppm sodium fluoride dentifrice

Locations

Country	Name	City	State
Chile	Faculty of Dentistry, University of Chile	Santiago	Región Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in mean VAS score per subject		Baseline, 4 and 8 weeks	No