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Comparison of Desensitizing Materials

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Fluoraphat Pro / VivaSens
Sponsored by
Nourah Mulfi Aljasser
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females aged between 18 and 50 years
  • Patient should have at least 2 teeth with dentinal hypersensitivity
  • Sound tooth structure
  • Willingness to participate in the study

Exclusion Criteria:

  • Gingival recession
  • Caries
  • Non-carious lesions (attrition, abrasion, erosion, abfraction)
  • Teeth restored with dental filling
  • Fractured or cracked tooth
  • Microleakage

Sites / Locations

  • Nourah Aljasser

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

desensitizing agents (Fluoraphat Pro and VivaSens®)

Arm Description

22 participants above the age of 18 years who presented to dental clinics in Riyadh Elm University with dentine hypersensitivity were randomly selected to participate in the study. Each participant has at least two teeth with natural hypersensitivity which was not caused by any iatrogenic causes or bad oral habits, so there are 44 cases divided into two groups according to the material used, each group has 22 teeth, that make it applicable to apply the studied material with every patient on individual tooth with the same variables of the oral mouth. When teeth in the hypersensitivity group were evaluated for the level of DH, all teeth were found to have Grade 4 sensitivity.

Outcomes

Primary Outcome Measures

Likert type scale used to measure attitudes or opinions
Likert type scale grading from 0-4 0: No sensitivity Very mild sensitivity Mild sensitivity Moderate Sensitivity Severe Sensitivity to compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2020
Last Updated
August 30, 2020
Sponsor
Nourah Mulfi Aljasser
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1. Study Identification

Unique Protocol Identification Number
NCT04527159
Brief Title
Comparison of Desensitizing Materials
Official Title
Comparison Between Two Different Desensitizing Materials in Controlling Natural Dentin Hypersensitivity: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 6, 2019 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourah Mulfi Aljasser

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.
Detailed Description
Dentine hypersensitivity (DH) is a condition that occurs in non-pathological, non-defective teeth and is defined as "a short, sharp pain in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be attributed to any other dental defect or pathology". The incidence of DH ranges from 4% to 74% in several studies. Mandibular first molars, canines and premolars of both jaws are most commonly affected by DH. The pathogenesis of DH is linked to exposure of dentinal tubules that can occur in the oral cavity due to dental erosion from acidogenic diets, aggressive tooth-brushing, injudicious use of whitening products, gingival recession, periodontal debridement or surgery. The most commonly reported initiating factor is cold drinks. Management usually involves methods that can achieve one or both of the following objectives; i) alteration of fluid flow in the dentinal tubules and ii) modification or blocking of the pulpal nerve response. A broad range of products that achieve these objectives have been developed after rigorous trials and can be used in-office or at home depending on the severity of the condition. These products are commonly referred to as desensitizing agents. Grossman suggested that an ideal desensitizing agent should be non-irritating to the pulp, relatively painless on application, easy to apply, rapid in action, effective for long periods of time and should not stain the teeth. The use of dentine desensitizers has become one of the most common methods in managing DH. The most commonly used desensitizers contain components such as fluoride, triclosan, benzalkonium chloride, ethylene diaminetetraacetic acid and glutaraldehyde. Fluoraphat Pro (Neumunster, Germany) and VivaSens® (Ivoclar Vivadent, Schaan, Liechtenstein, Switzerland) are two agents that have been tested for use as dentine desensitizers and are currently available for commercial use. In the present study, two such varnishes VivaSens (Ivoclar Vivadent, Schaan, Liechtenstein, and Switzerland) and Fluoraphat (Promedical Neumunster, Germany) have been used. The present study aims to establish which of the two desensitizing agents has better efficacy in reducing hypersensitivity in patients who have been previously diagnosed with DH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
desensitizing agents (Fluoraphat Pro and VivaSens®)
Arm Type
Other
Arm Description
22 participants above the age of 18 years who presented to dental clinics in Riyadh Elm University with dentine hypersensitivity were randomly selected to participate in the study. Each participant has at least two teeth with natural hypersensitivity which was not caused by any iatrogenic causes or bad oral habits, so there are 44 cases divided into two groups according to the material used, each group has 22 teeth, that make it applicable to apply the studied material with every patient on individual tooth with the same variables of the oral mouth. When teeth in the hypersensitivity group were evaluated for the level of DH, all teeth were found to have Grade 4 sensitivity.
Intervention Type
Drug
Intervention Name(s)
Fluoraphat Pro / VivaSens
Other Intervention Name(s)
VivaSens
Intervention Description
desensitizing agents for treatment of dentinal hypersensitivity
Primary Outcome Measure Information:
Title
Likert type scale used to measure attitudes or opinions
Description
Likert type scale grading from 0-4 0: No sensitivity Very mild sensitivity Mild sensitivity Moderate Sensitivity Severe Sensitivity to compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.
Time Frame
24 Hours

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Gender and Age are not included in the calculation, since the effects could not be determined reliably
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females aged between 18 and 50 years Patient should have at least 2 teeth with dentinal hypersensitivity Sound tooth structure Willingness to participate in the study Exclusion Criteria: Gingival recession Caries Non-carious lesions (attrition, abrasion, erosion, abfraction) Teeth restored with dental filling Fractured or cracked tooth Microleakage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roula Alboouni, Prof
Organizational Affiliation
Riyadh Elm University
Official's Role
Study Director
Facility Information:
Facility Name
Nourah Aljasser
City
Riyadh
ZIP/Postal Code
13311
Country
Saudi Arabia

12. IPD Sharing Statement

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Comparison of Desensitizing Materials

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