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This randomized split-mouth clinical trial evaluates enamel surface preservation, pulpal temperature variation, and patient-reported discomfort during ceramic orthodontic bracket removal using two Erbium-doped yttrium aluminum garnet (Er:YAG) laser parameter settings compared to conventional mechanical debonding. Pulpal temperature is monitored in real time using a thermocouple device. Enamel integrity is assessed using the Adhesive Remnant Index (ARI) under 40× magnification. The study aims to determine optimal laser parameters ensuring safe and conservative bracket removal.
Orthodontic bracket debonding must restore enamel close to its pretreatment condition while minimizing iatrogenic damage. Ceramic brackets demonstrate high bond strength and are associated with increased enamel fracture risk during conventional removal. Laser-assisted debonding has been proposed to reduce mechanical stress by softening the adhesive interface. However, concerns remain regarding pulpal temperature elevation and enamel surface alteration.
This randomized split-mouth clinical trial compares two Er:YAG laser parameter settings with conventional plier debonding. Pulpal temperature variation will be measured using a thermocouple inserted into the pulp chamber. Enamel surface evaluation will be performed using 40× magnification to assess ARI score. Pain perception will be recorded using a visual analog scale (VAS). The study aims to optimize laser parameters while ensuring biological safety and enamel preservation.
This split-mouth clinical trial includes 10 patients (100 maxillary teeth, teeth 15-25). Brackets are randomized by quadrant into:
Laser Parameter 1 (Er:YAG, 4 W, 400 mJ, 10 Hz)
Laser Parameter 2 (Er:YAG, 4.5 W, 300 mJ, 15 Hz)
Conventional mechanical debonding
Primary outcome: pulpal temperature variation (∆T). Secondary outcomes: ARI score and pain perception (VAS).
Laser irradiation is performed using LightWalker II ST-E Pro+ (Fotona, 2940 nm), non-contact mode, 45° angle, 1 cm distance, MicroShort pulse (MSP) mode, air=1, water=1, 10-15 seconds scanning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Er:YAG Laser - Parameter 1 | Experimental | Quadrants randomized to receive ceramic bracket removal using Er:YAG laser (Parameter Set 1) within a split-mouth design. Each participant serves as their own control, with the contralateral quadrant receiving conventional debonding. |
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| Er:YAG Laser - Parameter 2 | Experimental | Quadrants randomized to receive ceramic bracket removal using Er:YAG laser (Parameter Set 2) within a split-mouth design. Each participant serves as their own control, with the contralateral quadrant receiving conventional debonding. |
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| Conventional Mechanical Debonding | Experimental | Quadrants randomized to receive conventional ceramic bracket removal using orthodontic debonding pliers. In the split-mouth design, each participant also receives laser-assisted debonding on the contralateral quadrant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Er:YAG Laser - Parameter 1 | Device | Er:YAG laser (LightWalker II ST-E Pro+, Fotona, 2940 nm wavelength) applied in non-contact mode at 4 W average power, 400 mJ pulse energy, 10 Hz frequency, MSP mode (100 µs pulse duration), air=1 and water=1 settings. Laser applied at 45° angle, 1 cm distance, scanning method for 10-15 seconds until bracket detachment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulpal Temperature Variation (∆T) | Real-time pulp chamber temperature measured using a calibrated K-type thermocouple during laser irradiation. Temperature change recorded in degrees Celsius (°C). | During laser assisted bracket removal procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesive Remnant Index (ARI) | Microscopic evaluation at 40× magnification using Artun and Bergland scale (0-3). | Immediately after bracket removal |
| Pain Perception (VAS) | Patient-reported pain measured using a 10 cm Visual Analog Scale (0-10). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universite Saint Joseph, Faculte de Medecine | Beirut | 0000 | Lebanon |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2026 |
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split mouth design
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| Er:YAG Laser - Parameter 2 | Device | Er:YAG laser (LightWalker II ST-E Pro+, Fotona, 2940 nm wavelength) applied in non-contact mode at 4.5 W average power, 300 mJ pulse energy, 15 Hz frequency, MSP mode (100 µs pulse duration), air=1 and water=1 settings. Laser applied at 45° angle, 1 cm distance, scanning method for 10-15 seconds until bracket detachment. |
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| Conventional Mechanical Debonding | Procedure | Ceramic bracket removal using orthodontic debonding pliers (3M™ Unitek™ Debonding Instrument) applying controlled torsional force to bracket wings according to standard clinical protocol. |
|
| Immediately after each quadrant debonding |
| Mar 23, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 2, 2026 | Apr 3, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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