Clinical trial NCT06854068: Evaluation of the Combined Effect of Bioactive Toothpastes, Desensitizing Agents and Er-YAG Laser on Dentin Hypersensitivity: an In-Vivo Study
Official title: In-Vivo Evaluation of the Effect of Bioactive Material-Containing Toothpastes and Combined Use of Er-YAG Laser on Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dentin Hypersensitivity
Keywords: dentin hypersensitivity
laser
desensitization agent
toothpaste
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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!

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.

Primary outcomes:
measure: Change from Baseline in Dentin Hypersensitivity Scores Using VAS at 1 Week, 2 Weeks, 1 Month, and 3 Months After Treatment
timeFrame: Baseline (Pre-treatment), 15 Minutes After Initial Treatment, 1 Week, 2 Weeks, 1 Month, and 3 Months Post-Treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: