Clinical trial NCT03851900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Hypersensitivity
Keywords: Dentin hypersensitivity
Randomized clinical trial
Calcium phosphate desensitizer
Adhesive resin
VAS
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2019-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The effectiveness of desensitizers through long-term period
timeFrame: 6 months
Secondary outcomes:
measure: Subjective satisfaction of patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Arlin Kiremitci
role: STUDY_DIRECTOR
References: