NCT07517601

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

February 24, 2026

Last Update Submit

April 3, 2026

Conditions

PainTemperature ChangeLaserHealthy AdultOrthodontic Brackets

Keywords

ceramic bracketsorthodontic debondingenamel integritypulpal temperatureadhesive remnant indexpain assessmentErbium-doped Yttrium Aluminum Garnet Lasertooth enamel

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Adhesive Remnant Index (ARI)

    Immediately after bracket removal

  • Pain Perception (VAS)

    Immediately after each quadrant debonding

Study Arms (3)

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.

Procedure: Conventional Mechanical Debonding

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.

Procedure: Conventional Mechanical Debonding

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

Device: Er:YAG Laser - Parameter 1Device: Er:YAG Laser - Parameter 2

Interventions

Er:YAG Laser - Parameter 1DEVICE

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.

Conventional Mechanical Debonding
Er:YAG Laser - Parameter 2DEVICE

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
Conventional Mechanical DebondingPROCEDURE

Ceramic bracket removal using orthodontic debonding pliers (3M™ Unitek™ Debonding Instrument) applying controlled torsional force to bracket wings according to standard clinical protocol.

Er:YAG Laser - Parameter 1Er:YAG Laser - Parameter 2

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universite Saint Joseph, Faculte de Medecine

Beirut, 0000, Lebanon

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: split mouth design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2026

First Posted

April 8, 2026

Study Start

May 1, 2025

Primary Completion

April 30, 2026

Study Completion

May 30, 2026

Last Updated

April 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)