Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment

Dentine Hypersensitivity Clinical Trial

Official title:

Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018783
• Other study ID #: dessensibilizantes
• Status: Completed
• Phase: N/A
• First received: December 7, 2013
• Last updated: December 17, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline, immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used to assess the sensitivity level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 48 Years

Eligibility

Inclusion Criteria:

• subjects 18 years or older

• in good general and oral health; have complaint of CDH in teeth distributed in all 4 quadrants

• not making use of desensitizing agents

• not having undergone periodontal treatment over the past 3 months

• respond to evaporative stimulus with a score = 1.5 cm on VAS

Exclusion Criteria:

• patients who presented restorations and caries near the exposed dentin of the hypersensitive teeth

• who made frequent use of painkillers, anti-inflammatory and antidepressants drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

Procedure:
• Colgate
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
• Sensodyne
Digital application for 60 seconds.
• Nano P
Slow-speed handpiece with a Robson brush for 10 seconds
• Cocorico
Digital application for 60 seconds

Locations

Country	Name	City	State
Brazil	Periodontics Clinic, Department of Dentistry	Diamantina	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cervical dentin hypersensitivity	The cervical dentin hypersensitivity was evaluated by an air blast (evaporative stimulus) for 5 seconds, and by a tetrafluoroethane spray (cold stimulus) for 5 seconds.	30 days	Yes