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

April 3, 2026 updated by: Saint-Joseph University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon, 0000
        • Universite Saint Joseph, Faculte de Medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Er:YAG Laser - Parameter 1
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
Ceramic bracket removal using orthodontic debonding pliers (3M™ Unitek™ Debonding Instrument) applying controlled torsional force to bracket wings according to standard clinical protocol.
Experimental: Er:YAG Laser - Parameter 2
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
Ceramic bracket removal using orthodontic debonding pliers (3M™ Unitek™ Debonding Instrument) applying controlled torsional force to bracket wings according to standard clinical protocol.
Experimental: Conventional Mechanical Debonding
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
During laser assisted bracket removal procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adhesive Remnant Index (ARI)
Time Frame: Immediately after bracket removal
Microscopic evaluation at 40× magnification using Artun and Bergland scale (0-3).
Immediately after bracket removal
Pain Perception (VAS)
Time Frame: Immediately after each quadrant debonding
Patient-reported pain measured using a 10 cm Visual Analog Scale (0-10).
Immediately after each quadrant debonding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saint-Joseph University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRFMD A32/35 - CER-2025-233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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