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

February 25, 2025 updated by: Cem Peskersoy, Ege University

In-Vivo Evaluation of the Effect of Bioactive Material-Containing Toothpastes and Combined Use of Er-YAG Laser on Dentin Hypersensitivity

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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!

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Device: 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.
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
Other: 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.
Active Comparator: G2 Zubio
2-) Zubio (Nanohydroxyapatite, Turkey) Subgroup 2a: Laser Subgroup 2b: 3M Clinpro White Varnish (TCP, USA) Subgroup 2c: Control (distilled water)
Device: 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.
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
Other: 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.
Active Comparator: 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)
Device: 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.
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
Other: 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.
Active Comparator: 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)
Device: 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.
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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Baseline (Pre-treatment), 15 Minutes After Initial Treatment, 1 Week, 2 Weeks, 1 Month, and 3 Months Post-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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Collaborators

The Scientific and Technological Research Council of Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-70198063-050.04-2204953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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