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A Comparison of Long-Term Effectiveness of Two Desensitizing Products

Primary Purpose

Dentin Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Teethmate Desensitizer (TM)
Clearfil SE Bond 2
Distilled water
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring Dentin hypersensitivity, Randomized clinical trial, Calcium phosphate desensitizer, Adhesive resin, VAS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score
  2. Willingness to participate in the study

Exclusion Criteria:

  1. Subjects are unwilling to participate voluntarily
  2. Patients under 18 years old
  3. Those that were taking analgesic medicaments
  4. Pregnant and breastfeeding females
  5. The presence of a systemic disease that affects the participation
  6. Teeth with cervical loss of hard tissue that need restoration absolutely
  7. Large/defective restoration, caries or enamel cracks in sensitive teeth
  8. Teeth with vulnerability to hypersensitivity after root scaling
  9. Pulpitis presence.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Teethmate Desensitizer (TM)

Clearfil SE Bond 2 (SE)

Distilled water

Arm Description

Calcium phosphate biomimetic material that forms hydroxyapatite from tetracalcium phosphate and dicalcium phosphate anhydrous and plug the dentin tubules causing remineralization and dentin hypersensitivity relief.

Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing.

Distilled water with no desensitizing components.

Outcomes

Primary Outcome Measures

The effectiveness of desensitizers through long-term period
The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period. Evaluation will be performed usig the Visual Analog Scale(VAS). VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth.

Secondary Outcome Measures

Subjective satisfaction of patients
Because of the patient-centered aspect of the study patients' subjective satisfaction will be prior. Patients will be asked to define their sensitivity according to Visual Analog Scale (VAS) scale. VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. In case of persistant or recurrent sensitivity reported by the participants after application of desensitizing agents or placebo, even if the Visual Analog Scale score was decreased, it was accepted as failure, so alternative hypersensitivity treatments applied and current teeth will be excluded.

Full Information

First Posted
February 21, 2019
Last Updated
October 2, 2019
Sponsor
Baskent University
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03851900
Brief Title
A Comparison of Long-Term Effectiveness of Two Desensitizing Products
Official Title
A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
Collaborators
Hacettepe University

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
This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.
Detailed Description
The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months). At least fifty patients with a sensitivity score of 6 or higher, according to the Visual Analog Scale (VAS), with at least three teeth will participate in this study. Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo (distilled water) will be applied randomly to three teeth of each patient. Recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to VAS. The efficiency of the materials will be determined according to the VAS scores. Data will be analyzed using Paired t test and repeated measures of ANOVA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
Dentin hypersensitivity, Randomized clinical trial, Calcium phosphate desensitizer, Adhesive resin, VAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For each patient, selected teeth will be randomly assigned to TM, SE or placebo by the lottery method. The subjects will blind to the agent being used. All applications will be performed by the same examiner.
Masking
ParticipantInvestigator
Masking Description
The subjects will blind to the agent being used. At each recall the investigator used blank sheets with patients' names only to avoid bias relative to previous assessments
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teethmate Desensitizer (TM)
Arm Type
Experimental
Arm Description
Calcium phosphate biomimetic material that forms hydroxyapatite from tetracalcium phosphate and dicalcium phosphate anhydrous and plug the dentin tubules causing remineralization and dentin hypersensitivity relief.
Arm Title
Clearfil SE Bond 2 (SE)
Arm Type
Active Comparator
Arm Description
Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing.
Arm Title
Distilled water
Arm Type
Placebo Comparator
Arm Description
Distilled water with no desensitizing components.
Intervention Type
Other
Intervention Name(s)
Teethmate Desensitizer (TM)
Intervention Description
Desensitizing agent will be applied to sensitive teeth.
Intervention Type
Other
Intervention Name(s)
Clearfil SE Bond 2
Intervention Description
Desensitizing agent will be applied to sensitive teeth.
Intervention Type
Other
Intervention Name(s)
Distilled water
Intervention Description
Placebo will be applied to sensitive teeth as a negative control.
Primary Outcome Measure Information:
Title
The effectiveness of desensitizers through long-term period
Description
The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period. Evaluation will be performed usig the Visual Analog Scale(VAS). VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subjective satisfaction of patients
Description
Because of the patient-centered aspect of the study patients' subjective satisfaction will be prior. Patients will be asked to define their sensitivity according to Visual Analog Scale (VAS) scale. VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. In case of persistant or recurrent sensitivity reported by the participants after application of desensitizing agents or placebo, even if the Visual Analog Scale score was decreased, it was accepted as failure, so alternative hypersensitivity treatments applied and current teeth will be excluded.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score Willingness to participate in the study Exclusion Criteria: Subjects are unwilling to participate voluntarily Patients under 18 years old Those that were taking analgesic medicaments Pregnant and breastfeeding females The presence of a systemic disease that affects the participation Teeth with cervical loss of hard tissue that need restoration absolutely Large/defective restoration, caries or enamel cracks in sensitive teeth Teeth with vulnerability to hypersensitivity after root scaling Pulpitis presence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlin Kiremitci
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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A Comparison of Long-Term Effectiveness of Two Desensitizing Products

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