Dentin Hypersensitivity
Conditions
Keywords
Er,Cr;YSGG Laser, Remin Pro
Brief 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.
Interventions
DEVICEEr,Cr;YSGG Laser, Waterlase, Biolase Technology Inc., Irvine, CA, ABD
Er,Cr;YSGG Laser
DEVICERemin Pro (VOCO, Cuxhaven, Germany)
a hydroxyapatite-containing remineralizing agent
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Being between 18 and 70 years of age; voluntarily agreeing to participate in the study and providing written informed consent; not receiving any analgesic therapy; not having any systemic disease that could interfere with the treatment outcomes; not being pregnant or breastfeeding; presenting with at least four teeth exhibiting a Visual Analog Scale (VAS) score of 4 or higher; not exhibiting cervical abrasion-related substance loss of sufficient depth to require restorative treatment; absence of extensive or defective restorations or caries in the sensitive teeth; absence of pulpitis; and absence of hypersensitivity associated with recent periodontal procedures.
Exclusion criteria
Being younger than 18 years or older than 70 years of age; unwillingness to participate in the study voluntarily; receiving any analgesic therapy; presence of a systemic disease that could interfere with the treatment outcomes; being pregnant or breastfeeding; presence of substance loss of sufficient depth to require restorative treatment or the presence of enamel fracture; presence of extensive or defective restorations or caries in the sensitive teeth; presence of pulpitis; having received periodontal treatment within the three months prior to the initiation of the study and exhibiting persistent hypersensitivity related to that treatment; and developing a need for periodontal treatment (e.g., scaling or root planing) during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | From baseline to 12 month | Subjective pain perception is evaluated using a 100-mm Visual Analog Scale (VAS) ranging from '0 = No pain' to '10 = Worst pain imaginable.' Participants mark their perceived pain intensity on the scale following a 1-second air blast stimulus to the cervical area. The score is measured in millimeters from the zero anchor, with higher values indicating greater pain severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Schiff Cold Air Sensitivity Scale | From baseline to 12 month | Objective sensitivity is evaluated using the Schiff Cold Air Sensitivity Scale (0-3), based on the subject's reaction to an air stimulus. Scores are defined as: 0 (no response), 1 (response without requesting discontinuation), 2 (request to discontinue), and 3 (pain with evasive movement). Higher scores indicate greater dentin hypersensitivity. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAyşe Rüya Yazıcı, Prof.
Hacettepe University
PRINCIPAL_INVESTIGATOREzgi Yeşim Aybek Fırat
Hacettepe University
Outcome results
None listed