NCT07517601

Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical Trial

Evaluation of Enamel Surface and Pulpal Temperature for Ceramic Bracket Removal Using Two Laser Intensities Versus Conventional Technique: A Split-Mouth Clinical Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Orthodontic Brackets
• Pain
• Temperature Change
• Laser
• Healthy Adult

Interventions

Type	Name	Description
DEVICE	Er:YAG Laser - Parameter 1	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.
DEVICE	Er:YAG Laser - Parameter 2	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.
PROCEDURE	Conventional Mechanical Debonding	Ceramic bracket removal using orthodontic debonding pliers (3M™ Unitek™ Debonding Instrument) applying controlled torsional force to bracket wings according to standard clinical protocol.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: Lebanon