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NCT Number: NCT07517601

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

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.

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Key information

Conditions

Orthodontic Brackets Healthy Adult LASER Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Temperature Change

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universite Saint Joseph, Faculte de Medecine

Beirut, 0000, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-30 years
  • Completed orthodontic treatment
  • Maxillary teeth (15-25) bonded with 3M Clarity™ ceramic brackets
  • No analgesic use within 7 days
  • Good systemic health

Exclusion criteria

  • Smokers
  • Systemic diseases affecting oral health
  • Teeth with restorations or crowns
  • Pulp necrosis or infection
  • Medications affecting pulp vascular dynamics

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pulpal Temperature Variation (∆T)

    Time frame: During laser assisted bracket removal procedure

    Real-time pulp chamber temperature measured using a calibrated K-type thermocouple during laser irradiation. Temperature change recorded in degrees Celsius (°C).

Secondary outcomes

  1. Adhesive Remnant Index (ARI)

    Time frame: Immediately after bracket removal

    Microscopic evaluation at 40× magnification using Artun and Bergland scale (0-3).

  2. Pain Perception (VAS)

    Time frame: Immediately after each quadrant debonding

    Patient-reported pain measured using a 10 cm Visual Analog Scale (0-10).

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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