Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
Primary Purpose
Dentine Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Colgate
Sensodyne
Nano P
Cocorico
Sponsored by
About this trial
This is an interventional treatment trial for Dentine Hypersensitivity
Eligibility Criteria
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
Sites / Locations
- Periodontics Clinic, Department of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Sensodyne
Colgate
Nano P
Cocorico
Arm Description
Digital application for 60 seconds.
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
Slow-speed handpiece with a Robson brush for 10 seconds
Digital application for 60 seconds
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02018783
First Posted
December 7, 2013
Last Updated
December 17, 2013
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02018783
Brief Title
Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
Official Title
Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensodyne
Arm Type
Experimental
Arm Description
Digital application for 60 seconds.
Arm Title
Colgate
Arm Type
Experimental
Arm Description
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
Arm Title
Nano P
Arm Type
Experimental
Arm Description
Slow-speed handpiece with a Robson brush for 10 seconds
Arm Title
Cocorico
Arm Type
Placebo Comparator
Arm Description
Digital application for 60 seconds
Intervention Type
Procedure
Intervention Name(s)
Colgate
Intervention Description
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
Intervention Type
Procedure
Intervention Name(s)
Sensodyne
Intervention Description
Digital application for 60 seconds.
Intervention Type
Procedure
Intervention Name(s)
Nano P
Intervention Description
Slow-speed handpiece with a Robson brush for 10 seconds
Intervention Type
Procedure
Intervention Name(s)
Cocorico
Intervention Description
Digital application for 60 seconds
Primary Outcome Measure Information:
Title
cervical dentin hypersensitivity
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga D Flecha, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Periodontics Clinic, Department of Dentistry
City
Diamantina
State/Province
Minas Gerais
ZIP/Postal Code
39100000
Country
Brazil
12. IPD Sharing Statement
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Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
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