- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431736
Laser Therapy for Dentin Hypersensitivity
Clinical Evaluation of Laser Therapy for Dentin Hypersensitivity
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06100
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Er,Cr;YSGG Laser
The Er,Cr:YSGG laser (WaterLase iPlus) operates at 2780 nm, targeting water and hydroxyapatite for minimally invasive treatment.
It reduces dentin hypersensitivity through coagulation, recrystallization, and bio-stimulation, while minimizing thermal damage and micro-cracks compared to conventional tools.
This study evaluates the long-term individual and synergistic efficacy of this laser protocol combined with remineralizing agents to address gaps in the current literature regarding combined treatment modalities.
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Er,Cr;YSGG Laser
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Experimental: Remin Pro, a hydroxyapatite-containing remineralizing agent
Remin Pro (VOCO, Cuxhaven, Germany) is a desensitizing paste composed of hydroxyapatite, sodium fluoride, and xylitol.
Its therapeutic mechanism is primarily attributed to the physical occlusion of patent dentinal tubules by hydroxyapatite.
Additionally, sodium fluoride facilitates remineralization and enhances acid resistance, whereas xylitol contributes to the reduction of plaque formation through its antimicrobial properties.
This combination is applied to provide both symptomatic relief and surface protection for hypersensitive dentin.
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a hydroxyapatite-containing remineralizing agent
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Experimental: Combined Therapy: Er,Cr:YSGG Laser + Remin Pro
Subjects in this arm receive a sequential combined treatment protocol.
First, the hypersensitive dentin surface is irradiated with the Er,Cr:YSGG laser (WaterLase iPlus) using the parameters defined in the laser-only group (0.25 W, 20 Hz, 50 mJ, non-contact mode).
Immediately following the laser application, Remin Pro paste is applied to the target area using a micro-brush for 30 seconds.
This approach is designed to utilize the synergistic effects of laser-induced surface modification and the tubule-occluding properties of the remineralizing agent.
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Er,Cr;YSGG Laser
a hydroxyapatite-containing remineralizing agent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Scale
Time Frame: From baseline to 12 month
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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.
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From baseline to 12 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Schiff Cold Air Sensitivity Scale
Time Frame: From baseline to 12 month
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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.
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From baseline to 12 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayşe Rüya Yazıcı, Prof., Hacettepe University
- Principal Investigator: Ezgi Yeşim Aybek Fırat, Hacettepe University
Publications and helpful links
General Publications
- AlHabdan A, AlAhmari F. Phototherapy Using Er,Cr:YSGG Laser as a Definitive Treatment for Dentin Hypersensitivity: A Systematic Review. Int J Gen Med. 2022 May 11;15:4871-4880. doi: 10.2147/IJGM.S355890. eCollection 2022.
- Shukla K, Saxena A, Joshi J, Jain D. A Comparative Study of the Effect of Tooth Mousse Plus Remin Pro and Fluor Protector Gel on Enamel Erosion: An In Vitro Study. Int J Clin Pediatr Dent. 2023 Aug;16(Suppl 1):S57-S62. doi: 10.5005/jp-journals-10005-2602.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-61749811-000-4041535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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