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Not yet recruitingNCT06854068Updated Mar 3, 2025

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

An interventional study of laser treatment and application of desensitizing agent in Dentin Hypersensitivity, sponsored by Ege University. Not yet recruiting. Open to participants aged 18 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 84 Years
Sex
All
01

Study 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.

Read the 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!

02

Conditions studied

  • Dentin Hypersensitivity

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Keywords

  • dentin hypersensitivity
  • laser
  • desensitization agent
  • toothpaste
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Ege University is the lead sponsor of 377 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals over the age of 18,
  2. Individuals with good oral hygiene,
  3. Individuals without systemic 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
40 participants (estimated)

Study arms

  • 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 · Device: application of desensitizing agent · Other: Placebo

  • 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 · Device: application of desensitizing agent · Other: Placebo

  • 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 · Device: application of desensitizing agent · Other: Placebo

  • 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 · Device: application of desensitizing agent · Other: Placebo

Interventions

  • Devicelaser 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.

  • Deviceapplication 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

  • OtherPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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."

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06854068
Lead sponsor
Ege University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Cem Peskersoy (Doç. Dr., Ege University) — Principal investigator
First posted
Mar 3, 2025
Start date
May 1, 2025 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Mar 3, 2025

Study contacts

Cem Peşkersoy
Contact
dtcempeskersoy@hotmail.com
+905326362659
hilal bücekler
Contact
hilalbucekler@gmail.com
+905399884295

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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