Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity
Primary Purpose
Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
UltraEZ
Enamelast
Sponsored by
About this trial
This is an interventional treatment trial for Hypersensitivity Dentin
Eligibility Criteria
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
Sites / Locations
- Federal University of UberlândiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Neural agent
Obliterator agent
Associative approach
Arm Description
UltraEZ. Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Enamelast. Prophylaxis of the teeth; an application every 48 hours; 4 sessions
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.)
Outcomes
Primary Outcome Measures
Level of cervical dentin hypersensitivity by using visual analog scale
Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 24 weeks follow up.
Secondary Outcome Measures
Full Information
NCT ID
NCT03076944
First Posted
March 7, 2017
Last Updated
March 27, 2017
Sponsor
Federal University of Uberlandia
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT03076944
Brief Title
Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity
Official Title
Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do estado de Minas Gerais
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity Dentin, Dentin Sensitivity, Dentin Hypersensitivity, Dentine Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neural agent
Arm Type
Active Comparator
Arm Description
UltraEZ. Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Arm Title
Obliterator agent
Arm Type
Active Comparator
Arm Description
Enamelast. Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Arm Title
Associative approach
Arm Type
Active Comparator
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
UltraEZ
Intervention Description
Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.
Intervention Type
Drug
Intervention Name(s)
Enamelast
Intervention Description
Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.
Primary Outcome Measure Information:
Title
Level of cervical dentin hypersensitivity by using visual analog scale
Description
Evaluation of the reduction in dentin hypersensitivity levels by using visual analog scale with a 24 weeks follow up.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo V Soares, DDS,MS,PHD
Phone
+55 34 991615642
Email
paulovsoares@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo V Soares, DDS, MS, PHD
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Uberlândia
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
381440617
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo V Soares, DDS,MS,PHD
Phone
+55 34 991615642
Email
paulovsoares@yahoo.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7702459
Citation
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.
Results Reference
background
PubMed Identifier
24724135
Citation
Davari A, Ataei E, Assarzadeh H. Dentin hypersensitivity: etiology, diagnosis and treatment; a literature review. J Dent (Shiraz). 2013 Sep;14(3):136-45.
Results Reference
background
PubMed Identifier
12662460
Citation
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.
Results Reference
background
PubMed Identifier
5218158
Citation
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.
Results Reference
background
PubMed Identifier
22296690
Citation
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.
Results Reference
background
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Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity
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