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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07517601
Enrollment
10
Registered
2026-04-08
Start date
2025-05-01
Completion date
2026-05-30
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ceramic brackets, orthodontic debonding, enamel integrity, pulpal temperature, adhesive remnant index, pain assessment, Erbium-doped Yttrium Aluminum Garnet Laser, tooth enamel

Brief 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.

Interventions

DEVICEEr: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.

DEVICEEr: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.

PROCEDUREConventional 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.

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

split mouth design

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pulpal Temperature Variation (∆T)During laser assisted bracket removal procedureReal-time pulp chamber temperature measured using a calibrated K-type thermocouple during laser irradiation. Temperature change recorded in degrees Celsius (°C).

Secondary

MeasureTime frameDescription
Adhesive Remnant Index (ARI)Immediately after bracket removalMicroscopic evaluation at 40× magnification using Artun and Bergland scale (0-3).
Pain Perception (VAS)Immediately after each quadrant debondingPatient-reported pain measured using a 10 cm Visual Analog Scale (0-10).

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026