An interventional study of Teethmate Desensitizer (TM) and Clearfil SE Bond 2 in Dentin Hypersensitivity, sponsored by Baskent University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by Baskent University · Not applicable, Interventional, and Treatment
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.
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.
283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →Baskent University is the lead sponsor of 201 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
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)
Two-step self etch adhesive resin treating dentin hypersensitivity b covering a film layer after light-curing.
Other: Clearfil SE Bond 2
Distilled water with no desensitizing components.
Other: Distilled water
Desensitizing agent will be applied to sensitive teeth.
Desensitizing agent will be applied to sensitive teeth.
Placebo will be applied to sensitive teeth as a negative control.
The effectiveness of desensitizers through long-term period
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.
Time frame: 6 months
Subjective satisfaction of patients
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.
Time frame: 6 months
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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