Orthodontic BracketsNCT07517601
Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical Trial
A study testing Er:YAG Laser - Parameter 1, Er:YAG Laser - Parameter 2 and Conventional Mechanical Debonding in people with Orthodontic Brackets and Pain, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Orthodontic Brackets, Pain, Temperature Change
- What is being tested?
- Er:YAG Laser - Parameter 1, Er:YAG Laser - Parameter 2 and Conventional Mechanical Debonding
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLebanon
- Study dates
- 1 May 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Smokers
- Systemic diseases affecting oral health
- Teeth with restorations or crowns
- Pulp necrosis or infection
- Medications affecting pulp vascular dynamics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Er:YAG Laser - Parameter 1, Er:YAG Laser - Parameter 2, Conventional Mechanical Debonding
- Keywords
- ceramic brackets, orthodontic debonding, enamel integrity, pulpal temperature, adhesive remnant index, pain assessment, Erbium-doped Yttrium Aluminum Garnet Laser, tooth enamel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 DebondingProcedure or surgery
Ceramic bracket removal using orthodontic debonding pliers (3M™ Unitek™ Debonding Instrument) applying controlled torsional force to bracket wings according to standard clinical protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Device: Er:YAG Laser - Parameter 1; Device: Er:YAG Laser - Parameter 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During laser assisted bracket removal procedure
Secondary outcomes (2)
Adhesive Remnant Index (ARI)
Microscopic evaluation at 40× magnification using Artun and Bergland scale (0-3).
Measured: Immediately after bracket removal
Pain Perception (VAS)
Patient-reported pain measured using a 10 cm Visual Analog Scale (0-10).
Measured: Immediately after each quadrant debonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 May 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic BracketsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- split mouth design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517601
- Sponsor's protocol ID
- CRFMD A32/35 - CER-2025-233
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enamel Surface and Pulpal Temperature for Ceramic Bracket Removal Using Two Laser Intensities Versus Conventional Technique: A Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT07517601
- Acronym / sponsor ID
- CRFMD A32/35 - CER-2025-233
- Conditions
- Orthodontic Brackets, Pain, Temperature Change, Laser, Healthy Adult
- Keywords
- ceramic brackets, orthodontic debonding, enamel integrity, pulpal temperature, adhesive remnant index, pain assessment, Erbium-doped Yttrium Aluminum Garnet Laser, tooth enamel
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- split mouth design
| Arm | Type | Receives |
|---|---|---|
| Er:YAG Laser - Parameter 1 | Experimental | Procedure: Conventional Mechanical DebondingQuadrants 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. |
| Er:YAG Laser - Parameter 2 | Experimental | Procedure: Conventional Mechanical DebondingQuadrants 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. |
| Conventional Mechanical Debonding | Experimental | Device: Er:YAG Laser - Parameter 1, Device: Er:YAG Laser - Parameter 2Quadrants 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Smokers
- Systemic diseases affecting oral health
- Teeth with restorations or crowns
- Pulp necrosis or infection
- Medications affecting pulp vascular dynamics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Er:YAG Laser - Parameter 1Er: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 | Conventional Mechanical Debonding |
| Er:YAG Laser - Parameter 2Er: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. | Device | Conventional Mechanical Debonding |
| Conventional Mechanical DebondingCeramic bracket removal using orthodontic debonding pliers (3M™ Unitek™ Debonding Instrument) applying controlled torsional force to bracket wings according to standard clinical protocol. | Procedure or surgery | Er:YAG Laser - Parameter 1, Er:YAG Laser - Parameter 2 |
Primary outcome
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).
2 secondary outcomes
Adhesive Remnant Index (ARI)
Time frame: Immediately after bracket removal
Pain Perception (VAS)
Time frame: Immediately after each quadrant debonding
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er:YAG Laser - Parameter 1, Er:YAG Laser - Parameter 2 and Conventional Mechanical Debonding in people with Orthodontic Brackets and Pain, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulpal Temperature Variation (∆T) (time frame: During laser assisted bracket removal procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.