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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorEge University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals over the age of 18,

Individuals with good oral hygiene,

Individuals without systemic contraindications for treatment,

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

Disqualifiers

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

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

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

Individuals with unstable mental or physical conditions,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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 intervention

    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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: G1 ColgateActive comparator 3 interventions
Group B: G2 ZubioActive comparator 3 interventions
Group C: G3 SensodynActive comparator 3 interventions
Group D: G4 GCActive comparator 3 interventions

Trial outcomes

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.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ege University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator

This trial is not recruiting at the moment. You can still explore other options: