- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018783
Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
December 17, 2013 updated by: Olga Flecha, Federal University of São Paulo
Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
138
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
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Diamantina, Minas Gerais, Brazil, 39100000
- Periodontics Clinic, Department of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensodyne
Digital application for 60 seconds.
|
Digital application for 60 seconds.
|
|
Experimental: Colgate
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
|
Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
|
|
Experimental: Nano P
Slow-speed handpiece with a Robson brush for 10 seconds
|
Slow-speed handpiece with a Robson brush for 10 seconds
|
|
Placebo Comparator: Cocorico
Digital application for 60 seconds
|
Digital application for 60 seconds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cervical dentin hypersensitivity
Time Frame: 30 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olga D Flecha, PhD, Federal University of São Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
December 7, 2013
First Submitted That Met QC Criteria
December 17, 2013
First Posted (Estimate)
December 23, 2013
Study Record Updates
Last Update Posted (Estimate)
December 23, 2013
Last Update Submitted That Met QC Criteria
December 17, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- dessensibilizantes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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