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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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Here's the revised version with the corrected treatment and follow-up session schedule:
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The aim of this clinical trial is to evaluate the effectiveness of bioactive toothpastes, desensitizing agents, and Er-YAG laser treatments in reducing dentin hypersensitivity. This study also aims to assess the safety and comparative efficiency of these treatment methods. The main research questions are:
Participants will:
Researchers will compare the outcomes across groups using statistical analyses (Kolmogorov-Smirnov, Kruskal-Wallis, and Pearson/Spearman tests) to determine the most effective approach for managing dentin hypersensitivity.
In this study, 40 adult patients aged 18 years and older, with at least three teeth affected by dentin hypersensitivity, caries-free, vital, and periodontally healthy, will receive a combination of four different toothpastes, desensitizing agents, and Er-YAG laser treatment. The materials and study groups are organized as follows:
**Colgate Sensitive Pro-Relief** (Pro-argin, USA)
**Zubio** (Nano-hydroxyapatite, Turkey)
**Sensodyne Repair and Protect** (NovaMin, USA)
**GC Tooth Mousse** (CPP-ACP, Australia)
In the laser treatment groups, the Fotona LightWalker® Erbium laser (2,940 nm) will be used, with each session lasting five minutes. Energy intensity will be set at 20 J/cm², and the laser tip will be positioned perpendicularly to the target area, applied in continuous and contact modes. The desensitizing agent will consist of 3M Clinpro White Varnish containing Tri-Calcium Phosphate (TCP), applied according to the manufacturer's instructions.
Patients who have not used standard fluoride-containing toothpaste for at least one month prior to the study will be excluded to ensure baseline standardization among participants. The assigned toothpaste will be provided to patients according to their group allocation, and they will be instructed to use it three times daily for two minutes each time, without additional oral care products, until their third-month follow-up.
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Let me know if any additional modifications are needed!
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G1 Colgate | Active Comparator | Participants with dentin sensitivity in at least three teeth will be divided into four main groups. Subsequently, each of these main groups will be further divided into three subgroups. 1-) Colgate Sensitivity Pro-Solution (Pro-argin, USA) Subgroup 1a: Laser Subgroup 1b: 3M Clinpro White Varnish (TCP, USA) Subgroup 1c: Control (distilled water) |
|
| G2 Zubio | Active Comparator | 2-) Zubio (Nanohydroxyapatite, Turkey) Subgroup 2a: Laser Subgroup 2b: 3M Clinpro White Varnish (TCP, USA) Subgroup 2c: Control (distilled water) |
|
| G3 Sensodyn | Active Comparator | 3-) Sensodyne Repair and Protect (NovaMin, USA) Subgroup 3a: Laser Subgroup 3b: 3M Clinpro White Varnish (TCP, USA) Subgroup 3c: Control (distilled water) |
|
| G4 GC | Active Comparator | 4-) GC Tooth Mousse (CPP-ACP, Australia) Subgroup 4a: Laser Subgroup 4b: 3M Clinpro White Varnish (TCP, USA) Subgroup 4c: Control (distilled water) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laser treatment | Device | In the laser treatment groups, the Fotona LightWalker® Erbium laser (2,940 nm) will be used, with each session lasting five minutes. During treatment, the energy density will be set to 20 J/cm², and the laser tip will be held perpendicular to the target area, applied in continuous and contact modes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Dentin Hypersensitivity Scores Using VAS at 1 Week, 2 Weeks, 1 Month, and 3 Months After Treatment | Reduction in dentin hypersensitivity as assessed by the Visual Analog Scale (VAS) at baseline, immediately after treatment, 1 week, 2 weeks, 1 month, and 3 months post-treatment." | Baseline (Pre-treatment), 15 Minutes After Initial Treatment, 1 Week, 2 Weeks, 1 Month, and 3 Months Post-Treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cem PeÅŸkersoy | Contact | +905326362659 | dtcempeskersoy@hotmail.com | |
| hilal bücekler | Contact | +905399884295 | hilalbucekler@gmail.com |
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The participants will be aware of which toothpaste they are using; however, they will not know which of their teeth are receiving laser treatment or sensitivity-reducing agents. The evaluator, on the other hand, will be fully informed of all treatments administered.
The treatment will create the impression that a protective cover is being placed on the other teeth after applying the laser treatment to one tooth, although the laser will only be directed at the specified tooth. Similarly, the sensitivity-reducing agent will be applied to one tooth, while distilled water will be applied to the other sensitive teeth. This approach ensures that the participant will remain unaware of which treatment has been applied to which tooth, allowing for an unbiased assessment of sensitivity.
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| application of desensitizing agent | Device | Mix the product for 15 s. Apply in a thin layer on treatment area(s) with aid of a "microbrush", with no rinsing or removal |
|
| Placebo | Other | Simulation of a single layer application (15s) , with the aid of a "microbrush", on the surface of the tooth and with no rinsing or removal. |
|
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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