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A Comparison of Long-Term Effectiveness of Two Desensitizing Products

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: NCT03851900
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Hacettepe University
Information provided by (Responsible Party):
Leyla Kerimova, Baskent University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dentin Hypersensitivity Other: Teethmate Desensitizer (TM) Other: Clearfil SE Bond 2 Other: Distilled water Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
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
Primary Purpose: Treatment
Official Title: A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Teethmate Desensitizer (TM)
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.
 Other: Teethmate Desensitizer (TM)
Desensitizing agent will be applied to sensitive teeth.
Active Comparator: Clearfil SE Bond 2 (SE)
Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing.
 Other: Clearfil SE Bond 2
Desensitizing agent will be applied to sensitive teeth.
Placebo Comparator: Distilled water
Distilled water with no desensitizing components.
 Other: Distilled water
Placebo will be applied to sensitive teeth as a negative control.


Outcome Measures
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Primary Outcome Measures :
  1. The effectiveness of desensitizers through long-term period [ Time Frame: 6 months ]
    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 :
  1. Subjective satisfaction of patients [ Time Frame: 6 months ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT03851900


Locations
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Turkey
Hacettepe University
Ankara, Turkey
Sponsors and Collaborators
Baskent University
Hacettepe University
Investigators
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Study Director: Arlin Kiremitci Hacettepe University
More Information
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Responsible Party: Leyla Kerimova, Principal Investigator, Baskent University
ClinicalTrials.gov Identifier: NCT03851900    
Other Study ID Numbers: Hacettepe 2017/06-26 KA-16009
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leyla Kerimova, Baskent University:
Dentin hypersensitivity
Randomized clinical trial
Calcium phosphate desensitizer
Adhesive resin
VAS
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases