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Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076944
Recruitment Status : Unknown
Verified March 2017 by PAULO VINICIUS SOARES, Federal University of Uberlandia.
Recruitment status was:  Recruiting
First Posted : March 10, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
PAULO VINICIUS SOARES, Federal University of Uberlandia

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.

Condition or disease Intervention/treatment Phase
Hypersensitivity Dentin Dentin Sensitivity Dentin Hypersensitivity Dentine Hypersensitivity Drug: UltraEZ Drug: Enamelast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity: A Randomized Clinical Trial
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Neural agent
UltraEZ. Prophylaxis of the teeth; an application every 48 hours; 4 sessions
Drug: UltraEZ
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
Drug: Enamelast
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.)
Drug: UltraEZ
Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.

Drug: Enamelast
Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076944


Contacts
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Contact: Paulo V Soares, DDS,MS,PHD +55 34 991615642 paulovsoares@yahoo.com.br

Locations
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Brazil
Federal University of Uberlândia Recruiting
Uberlândia, Minas Gerais, Brazil, 381440617
Contact: Paulo V Soares, DDS,MS,PHD    +55 34 991615642    paulovsoares@yahoo.com.br   
Sponsors and Collaborators
Federal University of Uberlandia
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Investigators
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Principal Investigator: Paulo V Soares, DDS, MS, PHD Federal University of Uberlandia

Publications:
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Responsible Party: PAULO VINICIUS SOARES, Professor, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03076944    
Other Study ID Numbers: CAAE:60751416.1.0000.5152
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases