A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dentin Hypersensitivity
- Sponsor
- Baskent University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The effectiveness of desensitizers through long-term period
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Leyla Kerimova
Principal Investigator
Baskent University
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.
Outcomes
Primary Outcomes
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 Outcomes
- Subjective satisfaction of patients(6 months)