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

NCT06854068 | Not Yet Recruiting DMC

• 1 other identifier: E-70198063-050.04-2204953
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dentin Hypersensitivity

Keywords

dentin hypersensitivity; laser; desensitization agent; toothpaste

Outcome Measures

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."

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

Study Arms (4)

G1 Colgate

ACTIVE COMPARATOR

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

G2 Zubio

ACTIVE COMPARATOR

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

G3 Sensodyn

ACTIVE COMPARATOR

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

G4 GC

ACTIVE COMPARATOR

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

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.

G1 Colgate; G2 Zubio; G3 Sensodyn; G4 GC

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

G1 Colgate; G2 Zubio; G3 Sensodyn; G4 GC

Placebo 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.

G1 Colgate; G2 Zubio; G3 Sensodyn; G4 GC

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Individuals with sensitivity in at least three teeth,
• Individuals who have been using a standard toothpaste containing 1100 ppm fluoride for at least one month.

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Cem Peşkersoy

CONTACT

+905326362659; dtcempeskersoy@hotmail.com

hilal bücekler

CONTACT

+905399884295; hilalbucekler@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants will be aware of which toothpaste they are using; however, they will not know which of their teeth are receiving laser treatment or sensitivity-reducing agents. The evaluator, on the other hand, will be fully informed of all treatments administered. The treatment will create the impression that a protective cover is being placed on the other teeth after applying the laser treatment to one tooth, although the laser will only be directed at the specified tooth. Similarly, the sensitivity-reducing agent will be applied to one tooth, while distilled water will be applied to the other sensitive teeth. This approach ensures that the participant will remain unaware of which treatment has been applied to which tooth, allowing for an unbiased assessment of sensitivity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doç. Dr.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share