Trials / Active Not Recruiting
Active Not RecruitingNCT07431736
Laser Therapy for Dentin Hypersensitivity
Clinical Evaluation of Laser Therapy for Dentin Hypersensitivity
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Hacettepe University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
A 12-Month Comparative Clinical Evaluation of the Efficacy of Er,Cr:YSGG Laser Irradiation, Remin Pro Application, and Their Combined Therapy in the Treatment of Dentin Hypersensitivity.
Detailed description
This randomized, double-blind, parallel-group clinical trial is designed to evaluate the comparative efficacy of Er,Cr:YSGG laser irradiation, a desensitizing paste containing calcium sodium phosphosilicate, and their combined application in the treatment of dentin hypersensitivity. The study is conducted at the Department of Restorative Dentistry, Hacettepe University Faculty of Dentistry, involving 25 participants diagnosed with dentin hypersensitivity, from whom a minimum of three teeth meeting the inclusion criteria are selected. Prior to the commencement of the study, all participants provide written informed consent and undergo a standardization phase to control for confounding variables; this includes instruction on a specific atraumatic brushing technique and the exclusive use of a standard non-desensitizing fluoride toothpaste throughout the study duration. Following this phase, the selected teeth are randomly allocated to one of three treatment arms using a simple randomization method, while the investigator responsible for outcome assessment remains blinded to the group assignments to ensure the objectivity of the results. In the first intervention group, the tooth surfaces are cleaned with pumice and a rubber cup, rinsed, and dried, after which Remin Pro paste is applied to the sensitive cervical region using a micro-brush for 30 seconds in accordance with the manufacturer's instructions. The second intervention group receives Er,Cr:YSGG laser treatment (WaterLase iPlus) applied to the sensitive area; the laser parameters are set at a power output of 0.25 W, a frequency of 20 Hz, and an energy density of 50 mJ in a non-contact mode, with the tip held perpendicular to the surface at a distance of 1 mm and scanned over the target area for 60 seconds under water cooling. The third group undergoes a combined therapy protocol wherein the Er,Cr:YSGG laser irradiation is performed using the aforementioned parameters, immediately followed by the topical application of Remin Pro paste as described for the first group. All therapeutic interventions are administered in a single session, and no additional desensitizing treatments are applied during the subsequent 12-month observation period. Clinical efficacy is assessed at baseline, immediately post-treatment, and at follow-up intervals of 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months using two primary outcome measures: the Visual Analog Scale (VAS) for subjective pain assessment following a 1-second air blast stimulus, and the Schiff Cold Air Sensitivity Scale for objective evaluation of the reaction to an evaporative stimulus. Additionally, the impact of dentin hypersensitivity on the participants' oral health-related quality of life is evaluated using the Oral Health Impact Profile-14 (OHIP-14) questionnaire administered at baseline and at the conclusion of the 12-month follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Er,Cr;YSGG Laser, Waterlase, Biolase Technology Inc., Irvine, CA, ABD | Er,Cr;YSGG Laser |
| DEVICE | Remin Pro (VOCO, Cuxhaven, Germany) | a hydroxyapatite-containing remineralizing agent |
Timeline
- Start date
- 2025-11-11
- Primary completion
- 2025-11-18
- Completion
- 2026-12-11
- First posted
- 2026-02-25
- Last updated
- 2026-02-25
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07431736. Inclusion in this directory is not an endorsement.