Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
Study NCT ID:
NCT06854068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-03
First Post:
2025-02-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Combined Effect of Bioactive Toothpastes, Desensitizing Agents and Er-YAG Laser on Dentin Hypersensitivity: an In-Vivo Study
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
In-Vivo Evaluation of the Effect of Bioactive Material-Containing Toothpastes and Combined Use of Er-YAG Laser on Dentin Hypersensitivity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
* Do bioactive toothpastes, desensitizing agents, and laser treatments individually or in combination reduce dentin hypersensitivity?
* Are there any adverse effects associated with these treatments?
Participants will:
* Be randomly assigned to one of four treatment groups, each using a specific toothpaste (Pro-Argin, Nano-Hydroxyapatite, NovaMin, or CPP-ACP), alongside desensitizing agents, laser treatments, or a placebo.
* Receive two treatment sessions: the first at baseline and the second one week later.
* Attend follow-up evaluations at the 2nd week, 1st month, and 3rd month to assess dentin hypersensitivity using the Visual Analog Scale (VAS) and dental unit air-water sprays.
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.
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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:
* Do bioactive toothpastes, desensitizing agents, and laser treatments individually or in combination reduce dentin hypersensitivity?
* Are there any adverse effects associated with these treatments?
Participants will:
* Be randomly assigned to one of four treatment groups, each using a specific toothpaste (Pro-Argin, Nano-Hydroxyapatite, NovaMin, or CPP-ACP), alongside desensitizing agents, laser treatments, or a placebo.
* Receive two treatment sessions: the first at baseline and the second one week later.
* Attend follow-up evaluations at the 2nd week, 1st month, and 3rd month to assess dentin hypersensitivity using the Visual Analog Scale (VAS) and dental unit air-water sprays.
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.
Detailed Description:
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:
1. \*\*Colgate Sensitive Pro-Relief\*\* (Pro-argin, USA)
* Subgroup 1a: Laser
* Subgroup 1b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 1c: Control (distilled water)
2. \*\*Zubio\*\* (Nano-hydroxyapatite, Turkey)
* Subgroup 2a: Laser
* Subgroup 2b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 2c: Control (distilled water)
3. \*\*Sensodyne Repair and Protect\*\* (NovaMin, USA)
* Subgroup 3a: Laser
* Subgroup 3b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 3c: Control (distilled water)
4. \*\*GC Tooth Mousse\*\* (CPP-ACP, Australia)
* Subgroup 4a: Laser
* Subgroup 4b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 4c: Control (distilled water)
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!
1. \*\*Colgate Sensitive Pro-Relief\*\* (Pro-argin, USA)
* Subgroup 1a: Laser
* Subgroup 1b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 1c: Control (distilled water)
2. \*\*Zubio\*\* (Nano-hydroxyapatite, Turkey)
* Subgroup 2a: Laser
* Subgroup 2b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 2c: Control (distilled water)
3. \*\*Sensodyne Repair and Protect\*\* (NovaMin, USA)
* Subgroup 3a: Laser
* Subgroup 3b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 3c: Control (distilled water)
4. \*\*GC Tooth Mousse\*\* (CPP-ACP, Australia)
* Subgroup 4a: Laser
* Subgroup 4b: 3M Clinpro White Varnish (TCP, USA)
* Subgroup 4c: Control (distilled water)
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!
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: