Evaluation of the Combined Effect of Bioactive Toothpastes, Desensitizing Agents and Er-YAG Laser on Dentin Hypersensitivity: an In-Vivo Study

NCT ID: NCT06854068

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-09-01

Brief Summary

Here's the revised version with the corrected treatment and follow-up session schedule:

---

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.

---

Let me know if any additional modifications are needed!

Conditions

Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

G1 Colgate

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)

Group Type: ACTIVE_COMPARATOR

laser treatment

Intervention Type: 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.

application of desensitizing agent

Intervention Type: 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

Intervention Type: 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.

G2 Zubio

2-) Zubio (Nanohydroxyapatite, Turkey) Subgroup 2a: Laser Subgroup 2b: 3M Clinpro White Varnish (TCP, USA) Subgroup 2c: Control (distilled water)

Group Type: ACTIVE_COMPARATOR

laser treatment

Intervention Type: 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.

application of desensitizing agent

Intervention Type: 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

Intervention Type: 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.

G3 Sensodyn

3-) Sensodyne Repair and Protect (NovaMin, USA) Subgroup 3a: Laser Subgroup 3b: 3M Clinpro White Varnish (TCP, USA) Subgroup 3c: Control (distilled water)

Group Type: ACTIVE_COMPARATOR

laser treatment

Intervention Type: 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.

application of desensitizing agent

Intervention Type: 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

Intervention Type: 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.

G4 GC

4-) GC Tooth Mousse (CPP-ACP, Australia) Subgroup 4a: Laser Subgroup 4b: 3M Clinpro White Varnish (TCP, USA) Subgroup 4c: Control (distilled water)

Group Type: ACTIVE_COMPARATOR

laser treatment

Intervention Type: 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.

application of desensitizing agent

Intervention Type: 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

Intervention Type: 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.

Interventions

laser treatment

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.

Intervention Type: DEVICE

application of desensitizing agent

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

Intervention Type: DEVICE

Placebo

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Individuals over the age of 18,

2. Individuals with good oral hygiene,

3. Individuals without systemic contraindications for treatment,

4. Individuals who are reliable for periodic follow-ups, cooperative, and willing to participate in the study,

5. Individuals with sensitivity in at least three teeth,

6. Individuals who have been using a standard toothpaste containing 1100 ppm fluoride for at least one month.

Exclusion Criteria

1. Individuals with a history of alcohol, drug, or medication addiction,

2. Individuals known to be unable to attend follow-up sessions,

3. Individuals with allergies to any of the products used in the study,

4. Individuals with unstable mental or physical conditions,

5. Pregnant or breastfeeding individuals, as well as those planning pregnancy during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Cem Peskersoy

Doç. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Cem Peşkersoy

Role: CONTACT

dtcempeskersoy@hotmail.com

+905326362659

hilal bücekler

Role: CONTACT

hilalbucekler@gmail.com

+905399884295

Other Identifiers

E-70198063-050.04-2204953

Identifier Type: -

Identifier Source: org_study_id