- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076944
Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity
March 27, 2017 updated by: PAULO VINICIUS SOARES, Federal University of Uberlandia
Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity: A Randomized Clinical Trial
The aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity.
The desensitization approach (single agent or associated agents) and the long-term effectiveness (baseline, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks) will be evaluated.
Data will be collected, tabulated and submitted to statistical analysis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Dentin hypersensitivity is characterized as an acute and short-term pain with multifactorial etiology.
This condition is a clinical challenge due to the different treatment protocols available.
Therefore, the aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity.
Thirty-two patients with dentin hypersensitivity in at least three teeth will be selected.The teeth will be randomly divided into two different groups according to the desensitization approach (single agent with neural action; single agent with obliterating action; associated technique (neural and obliterator agents).
The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2, 4,12 and 24 weeks.
Data will be collected, tabulated and submitted to statistical analysis.
Study Type
Interventional
Enrollment (Anticipated)
32
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 Contact
- Name: Paulo V Soares, DDS,MS,PHD
- Phone Number: +55 34 991615642
- Email: paulovsoares@yahoo.com.br
Study Locations
-
-
Minas Gerais
-
Uberlândia, Minas Gerais, Brazil, 381440617
- Recruiting
- Federal University of Uberlandia
-
Contact:
- Paulo V Soares, DDS,MS,PHD
- Phone Number: +55 34 991615642
- Email: paulovsoares@yahoo.com.br
-
-
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
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy individuals
- Both genres, interested in the treatment of Dentin Hypersensitivity
- Patients with all teeth in their mouth
- Patients who have at least three teeth with Dentin hypersensitivity in different quadrants
- Good oral hygiene
Exclusion Criteria:
- Caries or unsatisfactory restorations
- Presence of periodontal disease and or parafunctional habits
- Cracks or enamel fractures
- Extensive or unsatisfactory restorations
- Recent restorations involving the labial surface
- Pulpitis
- Dentures
- Orthodontics
- Smokers
- Pregnant women
- Gastroesophageal disease presence
- Uncontrolled systemic disease
- Severe bruxism
- Constant use of analgesic
- Allergic response to dental products
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: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Neural agent
UltraEZ.
Prophylaxis of the teeth; an application every 48 hours; 4 sessions
|
Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.
|
ACTIVE_COMPARATOR: Obliterator agent
Enamelast.
Prophylaxis of the teeth; an application every 48 hours; 4 sessions
|
Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.
|
ACTIVE_COMPARATOR: Associative approach
UltraEZ and Enamelast.
Prophylaxis of the teeth; an application every 48 hours; 4 sessions.
In each session, fistly the UltraEZ (neural agent) will be applied and after the Enamelast (obliterator agent.)
|
Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.
Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of cervical dentin hypersensitivity by using visual analog scale
Time Frame: 24 weeks
|
Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 24 weeks follow up.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paulo V Soares, DDS, MS, PHD, Federal University of Uberlandia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Orchardson R, Gangarosa LP Sr, Holland GR, Pashley DH, Trowbridge HO, Ashley FP, Kleinberg I, Zappa U. Dentine hypersensitivity-into the 21st century. Arch Oral Biol. 1994;39 Suppl:113S-119S. doi: 10.1016/0003-9969(94)90197-x. No abstract available.
- Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45.
- Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.
- Brannstrom M. Sensitivity of dentine. Oral Surg Oral Med Oral Pathol. 1966 Apr;21(4):517-26. doi: 10.1016/0030-4220(66)90411-7. No abstract available.
- Grippo JO, Simring M, Coleman TA. Abfraction, abrasion, biocorrosion, and the enigma of noncarious cervical lesions: a 20-year perspective. J Esthet Restor Dent. 2012 Feb;24(1):10-23. doi: 10.1111/j.1708-8240.2011.00487.x. Epub 2011 Nov 17.
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 (ACTUAL)
March 20, 2017
Primary Completion (ANTICIPATED)
November 1, 2017
Study Completion (ANTICIPATED)
March 1, 2018
Study Registration Dates
First Submitted
March 7, 2017
First Submitted That Met QC Criteria
March 9, 2017
First Posted (ACTUAL)
March 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE:60751416.1.0000.5152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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