A Comparison of Long-Term Effectiveness of Two Desensitizing Products

Baskent University

Status: Completed

Conditions: Dentin Hypersensitivity

Treatments: Other: Teethmate Desensitizer (TM); Other: Distilled water; Other: Clearfil SE Bond 2

Study type: Interventional

Funder types: Other

Identifiers

NCT03851900

Hacettepe 2017/06-26 KA-16009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

Teethmate Desensitizer (TM)

Experimental group

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.

Treatment:

Other: Teethmate Desensitizer (TM)

Clearfil SE Bond 2 (SE)

Active Comparator group

Description:

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

Treatment:

Other: Clearfil SE Bond 2

Distilled water

Placebo Comparator group

Description:

Distilled water with no desensitizing components.

Treatment:

Other: Distilled water