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This randomized controlled clinical trial aims to compare the effectiveness of Erbium laser (2940 nm), Diode laser (650 nm), combination Diode laser with fluoride varnish, and fluoride varnish alone in treating dentinal hypersensitivity. The study will recruit 96 adults aged 18-45 years with tooth sensitivity scores ≥4 on a 0-10 Visual Analogue Scale, randomly allocating 24 participants to each of four treatment groups. The primary outcome is reduction in tooth sensitivity measured at baseline, 1 week, 4 weeks, and 6 months post-treatment, with patient satisfaction as a secondary outcome. Conducted at Cairo University's Faculty of Dentistry, this 6-month follow-up study addresses the limitation of current treatments that provide only temporary relief, seeking to establish evidence-based protocols for optimal long-term management of dentinal hypersensitivity by evaluating whether laser therapies alone or in combination with fluoride offer superior and more durable pain relief compared to standard fluoride treatment alone.
This randomized controlled clinical trial investigates the comparative efficacy of different laser systems and fluoride-based treatments for managing dentinal hypersensitivity, a prevalent clinical condition characterized by sharp, transient pain from exposed dentin in response to thermal, evaporative, tactile, or chemical stimuli. The study will recruit 96 participants aged 18-45 years with dentinal hypersensitivity scores ≥4 on a Visual Analogue Scale (VAS), randomly allocating them into four equal groups (n=24 each): Group 1 receiving Erbium:YAG laser treatment (2940 nm, 80mJ, 2Hz) which works through thermal tubule occlusion; Group 2 receiving Diode laser photobiomodulation therapy (650 nm, 100mW, 2J total dose) targeting neural modulation; Group 3 receiving combination therapy of Diode laser with 5% sodium fluoride varnish to exploit synergistic mechanisms; and Group 4 receiving fluoride varnish alone as the control comparator. The primary outcome measures dentinal hypersensitivity reduction using VAS scores (0-10 scale) assessed through standardized evaporative stimulus tests at baseline, 1 week, 4 weeks, and 6 months post-treatment, while secondary outcomes include patient satisfaction and treatment tolerability. Conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with blinded outcome assessors and standardized protocols, this superiority trial addresses the clinical need for evidence-based, long-term effective treatments for dentinal hypersensitivity by comparing individual laser modalities against combination therapy and established fluoride treatments, potentially establishing optimal therapeutic protocols that provide both immediate relief and sustained tubule occlusion or neural modulation for improved patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erbium Laser | Experimental | Erbium:YAG laser (2940 nm) treatment alone using thermal ablation to seal dentinal tubules and reduce hypersensitivity. |
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| Diode Laser | Experimental | Diode laser (650 nm) photobiomodulation therapy alone targeting neural modulation to reduce pain transmission. |
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| Combination Therapy | Experimental | Diode laser (650 nm) followed immediately by fluoride varnish application combining neural modulation with tubule occlusion. |
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| Fluoride Control | Active Comparator | 5% sodium fluoride varnish alone serving as active control, promoting remineralization and tubule occlusion through standard treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbium laser (2940 nm): Infrared light energy | Other | The lasers emit light energy in the infrared and visible spectrum, which is fundamentally different from ionizing radiation (like X-rays or gamma rays) that can damage DNA. Dental lasers work through photobiomodulation and thermal effects, not through radiation exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Dentinal Hypersensitivity Assessment | Dentinal Hypersensitivity Assessment Using Visual Analogue Scale | at baseline, 1 week, 4 weeks, and 6 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | The secondary outcome measures patient satisfaction with treatment using a categorical Yes/No assessment. Participants report their overall satisfaction with the assigned intervention based on perceived pain relief. | at baseline, 1 week, 4 weeks, and 6 months post-treatment |
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Inclusion Criteria
Exclusion Criteria
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This randomized controlled trial uses a single-blind, parallel-group design to compare four treatments for dentinal hypersensitivity in 96 participants. Using computer-generated randomization and sealed envelope allocation, participants are equally divided into four groups receiving Erbium laser, Diode laser, combination Diode laser with fluoride, or fluoride alone. The study employs blinded outcome assessors, sham procedures to minimize bias, and follows participants for 6 months with Visual Analogue Scale measurements at baseline, 1 week, 4 weeks, and 6 months to assess treatment effectiveness.
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This randomized controlled trial uses a single-blind, parallel-group design to compare four treatments for dentinal hypersensitivity in 96 participants. Using computer-generated randomization and sealed envelope allocation, participants are equally divided into four groups receiving Erbium laser, Diode laser, combination Diode laser with fluoride, or fluoride alone. The study employs single-blind masking where outcome assessors and statisticians remain blinded to treatment assignments, while sham procedures (simulated laser/fluoride applications) minimize bias where complete blinding is impossible. Participants are followed for 6 months with Visual Analogue Scale measurements at baseline, 1 week, 4 weeks, and 6 months to assess treatment effectiveness using standardized protocols and pre-calibrated examiners.
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| Diode laser (650 nm): Visible red light energy | Other | Non-ionizing radiation or more accurately as optical energy devices, not ionizing radiation. |
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| Fluoride varnish | Drug | Biological Intervention |
|
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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