A Comparison of Long-Term Effectiveness of Two Desensitizing Products

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dentin Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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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.

Group Type EXPERIMENTAL

Teethmate Desensitizer (TM)

Intervention Type OTHER

Desensitizing agent will be applied to sensitive teeth.

Clearfil SE Bond 2 (SE)

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

Group Type ACTIVE_COMPARATOR

Clearfil SE Bond 2

Intervention Type OTHER

Desensitizing agent will be applied to sensitive teeth.

Distilled water

Distilled water with no desensitizing components.

Group Type PLACEBO_COMPARATOR

Distilled water

Intervention Type OTHER

Placebo will be applied to sensitive teeth as a negative control.

Interventions

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Teethmate Desensitizer (TM)

Desensitizing agent will be applied to sensitive teeth.

Intervention Type OTHER

Clearfil SE Bond 2

Desensitizing agent will be applied to sensitive teeth.

Intervention Type OTHER

Distilled water

Placebo will be applied to sensitive teeth as a negative control.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes