Bracket BondingNCT07091422
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
A study testing Etch-Free Adhesive and Conventional Etch-and-Bond Adhesive in people with Bracket Bonding and Orthodontic Treatment, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This randomized, split-mouth clinical trial will evaluate a new orthodontic adhesive that eliminates the need for acid etching before bracket bonding. Conventional orthodontic bonding requires etching enamel with phosphoric acid, which can weaken the outer enamel layer and increase the risk of white spot lesions and… Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bracket Bonding, Orthodontic Treatment, Dental Adhesives/Restorations Performance
- What is being tested?
- Etch-Free Adhesive and Conventional Etch-and-Bond Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 1 Dec 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 14 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 14 to 35 years
- Requiring comprehensive fixed orthodontic treatment with brackets on both arches
- Good general health with no contraindications to orthodontic treatment
- Presence of at least 10 permanent teeth per arch suitable for bracket bonding
- Ability and willingness to comply with study visits and follow-up for at least 12 months
- Parent/guardian consent and child assent obtained as appropriate
Who cannot join
- Presence of systemic diseases or conditions that affect oral health or healing (e.g., uncontrolled diabetes, immunosuppression)
- Teeth with significant enamel defects, restorations, or caries in bonding areas
- Patients currently undergoing or who have undergone orthodontic treatment previously
- History of allergy or sensitivity to dental adhesives or related materials
- Patients with poor oral hygiene or active periodontal disease
- Use of medications known to affect tooth enamel or oral tissues (e.g., long-term corticosteroids)
- Inability to attend follow-up visits or anticipated lack of compliance
- Participation in another clinical trial that could interfere with study outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Baltimore School of Dentistry
Baltimore, Maryland, 21201
Vineet Vineet, DDS, PhD, 410 706 7970, vdhar@umaryland.edu
Flavio Copello, DDS, MSc, PhD
About this study
This randomized, split-mouth clinical trial will evaluate a new orthodontic adhesive that eliminates the need for acid etching before bracket bonding. Conventional orthodontic bonding requires etching enamel with phosphoric acid, which can weaken the outer enamel layer and increase the risk of white spot lesions and enamel damage. The etch-free adhesive under investigation is designed to simplify the bonding procedure while preserving enamel integrity.
Twenty orthodontic patients starting treatment with braces will participate. For each patient, one side of the mouth (left or right) will be randomly assigned to receive the etch-free adhesive, while the opposite side will receive the conventional adhesive with acid etching. This intra-patient design allows a direct comparison under identical oral conditions.
Participants will be followed for 12 months. Bracket failures, bonding time, ease of adhesive removal, enamel surface condition after debonding, and the presence of white spot lesions will be recorded. If effective, the etch-free adhesive may reduce enamel damage without compromising bond strength, providing a safer and more efficient bonding option for orthodontic patients.
Read the detailed description
This is a prospective, randomized, split-mouth clinical trial designed to compare the bond failure rate, bonding efficiency, and enamel outcomes of a novel etch-free orthodontic adhesive with a conventional acid-etch adhesive over a 12-month follow-up period.
Background and Rationale Conventional orthodontic bonding requires phosphoric acid etching to create surface roughness for adhesive retention. While effective, this process irreversibly demineralizes enamel and may increase susceptibility to white spot lesions (WSLs), decalcification, and enamel fractures during bracket removal.
A new generation of self-adhesive bonding materials eliminates the etching step by bonding directly to enamel. This simplified approach may preserve enamel integrity, reduce chair time, and improve the patient experience while maintaining adequate bond strength.
The split-mouth design allows direct intra-patient comparison of the two bonding methods under identical oral conditions (hygiene, diet, occlusal forces), reducing inter-patient variability.
Study Design Type: Prospective, randomized, split-mouth trial
Population: 20 patients (ages ≥12 years) with permanent dentition undergoing fixed orthodontic treatment
Follow-up duration: 12 months post-bonding
Setting: University-based orthodontic clinic
Interventions Test Adhesive (Experimental): A commercially available etch-free adhesive system applied directly to enamel without acid etching or separate priming.
Control Adhesive: Conventional orthodontic adhesive applied following 37% phosphoric acid etching, primer, and adhesive placement.
Randomization and Bonding Procedure Each patient will receive both adhesives-one on the left side and one on the right-randomly assigned using a computer-generated randomization schedule and sealed envelopes.
Bonding will be performed by a calibrated operator using identical brackets and bonding techniques.
Control side: 37% phosphoric acid etch (30 seconds), rinse, dry, primer, and adhesive.
Experimental side: Etch-free adhesive applied directly per manufacturer instructions.
Bonding time for each side will be measured with a stopwatch.
Sample Size Justification Twenty patients will contribute approximately 212 bonded brackets (10-12 per side, excluding molars and second premolars). This sample size provides 80% power to detect a clinically meaningful difference in bond failure rates (expected 5% failure rate for the etch-free adhesive vs. 10% for conventional adhesive; α = 0.05), analyzed using McNemar's test for paired binary outcomes.
Outcome Measures Primary Outcome
Bracket Failure Rate: Number and location of dislodged brackets on test vs. control sides recorded at monthly visits.
Secondary Outcomes
Bonding Time: Measured in seconds per side.
Enamel Condition at Debonding: Assessed clinically and photographically by blinded evaluators.
Adhesive Remnant Index (ARI): Scored 0-3 after debonding.
White Spot Lesions (WSLs): Presence and severity assessed clinically and photographically at baseline and after 12 months using standardized scoring.
Patient-Reported Outcomes (if applicable): Discomfort related to bonding/debonding.
Data Collection and Management Data will be recorded using standardized forms and stored on secure, encrypted institutional servers.
Clinical photographs will document enamel condition and WSLs.
All data will be coded and de-identified. Only authorized study personnel will have access.
Ethical Considerations The study has been reviewed by the University of Maryland Institutional Review Board (IRB #HP-00115604) and determined to be minimal risk.
Written informed consent will be obtained from adult participants; minors will provide assent with parental consent.
Both adhesives are commercially available and widely used in clinical practice; no experimental drugs or devices are involved.
No additional radiographs or invasive procedures are required beyond standard care.
Participants may withdraw at any time without affecting their ongoing treatment.
This trial seeks to determine whether an etch-free adhesive can reduce enamel damage and improve bonding efficiency without compromising clinical performance.
- Conditions
- Bracket Bonding, Orthodontic Treatment, Dental Adhesives/Restorations Performance, White Spot Lesion of Tooth
- Being tested
- Etch-Free Adhesive, Conventional Etch-and-Bond Adhesive
- Keywords
- Etch-Free Adhesive, Orthodontic Bonding, Bracket Failure, Split-Mouth Trial, White Spot Lesions, Orthodontics Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etch-Free AdhesiveDevice
A self-adhesive orthodontic bonding material applied directly to enamel without prior phosphoric acid etching or primer application. Brackets are bonded following the manufacturer's instructions.
Conventional Etch-and-Bond AdhesiveDevice
A standard orthodontic bonding protocol using 35-37% phosphoric acid etching, primer application, and a conventional light-cure adhesive. Brackets are bonded following the manufacturer's recommended procedure.
| Study group | Role | What they receive |
|---|---|---|
| Etch-Free Adhesive | Experimental | Teeth on one randomized side of the mouth will be bonded with a novel self-adhesive orthodontic material that does not require prior acid etching or primer application. Receives: Device: Etch-Free Adhesive |
| Conventional Etch-and-Bond Adhesive | Experimental | Teeth on the contralateral side of the mouth will be bonded using the standard orthodontic bonding protocol with 35-37% phosphoric acid etching, primer, and conventional resin adhesive. Receives: Device: Conventional Etch-and-Bond Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bracket Failure Rate
The proportion of brackets bonded with each adhesive (etch-free vs. conventional) that experience bond failure over a 12-month follow-up period. A bond failure is defined as a clinically detached bracket requiring rebonding.
Measured: Through study completion, up to 12 months post-bonding (evaluated at each routine orthodontic visit).
Secondary outcomes (4)
Bonding Time Per Quadrant
The time required to bond all brackets in one quadrant using either adhesive, measured in minutes using a digital timer.
Measured: At the initial bonding appointment (Day 1).
Adhesive Remnant Index (ARI) at Debonding
The amount of adhesive remaining on the tooth surface after bracket removal, scored using the standardized Adhesive Remnant Index (0-3 scale).
Measured: At debonding (approximately 12 months post-bonding or at completion of treatment).
Enamel Surface Integrity
Visual assessment of enamel for cracks, roughness, or damage after bracket removal, evaluated through clinical inspection and standardized digital photographs.
Measured: At debonding (approximately 12 months post-bonding).
White Spot Lesion (WSL) Formation
Incidence and severity of new white spot lesions on bonded teeth, assessed using a standardized WSL index at 6 and 12 months.
Measured: At baseline (Day 1), 6 months, and 12 months post-bonding.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start5 Nov 2025
- Primary completion11 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bracket BondingStudies 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
- Crossover
- Model description
- Split-mouth
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavio Copello, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091422
- Sponsor's protocol ID
- HP-00115604
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study involves minimal-risk clinical data and will be reported in aggregate form only. De-identified individual participant data will not be shared outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
- ClinicalTrials.gov ID
- NCT07091422
- Acronym / sponsor ID
- HP-00115604
- Conditions
- Bracket Bonding, Orthodontic Treatment, Dental Adhesives/Restorations Performance, White Spot Lesion of Tooth
- Keywords
- Etch-Free Adhesive, Orthodontic Bonding, Bracket Failure, Split-Mouth Trial, White Spot Lesions, Orthodontics Clinical Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 11 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Jul 2025 (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 will evaluate a new orthodontic adhesive that eliminates the need for acid etching before bracket bonding. Conventional orthodontic bonding requires etching enamel with phosphoric acid, which can weaken the outer enamel layer and increase the risk of white spot lesions and enamel damage. The etch-free adhesive under investigation is designed to simplify the bonding procedure while preserving enamel integrity.
Twenty orthodontic patients starting treatment with braces will participate. For each patient, one side of the mouth (left or right) will be randomly assigned to receive the etch-free adhesive, while the opposite side will receive the conventional adhesive with acid etching. This intra-patient design allows a direct comparison under identical oral conditions.
Participants will be followed for 12 months. Bracket failures, bonding time, ease of adhesive removal, enamel surface condition after debonding, and the presence of white spot lesions will be recorded. If effective, the etch-free adhesive may reduce enamel damage without compromising bond strength, providing a safer and more efficient bonding option for orthodontic patients.
Detailed description
This is a prospective, randomized, split-mouth clinical trial designed to compare the bond failure rate, bonding efficiency, and enamel outcomes of a novel etch-free orthodontic adhesive with a conventional acid-etch adhesive over a 12-month follow-up period.
Background and Rationale Conventional orthodontic bonding requires phosphoric acid etching to create surface roughness for adhesive retention. While effective, this process irreversibly demineralizes enamel and may increase susceptibility to white spot lesions (WSLs), decalcification, and enamel fractures during bracket removal.
A new generation of self-adhesive bonding materials eliminates the etching step by bonding directly to enamel. This simplified approach may preserve enamel integrity, reduce chair time, and improve the patient experience while maintaining adequate bond strength.
The split-mouth design allows direct intra-patient comparison of the two bonding methods under identical oral conditions (hygiene, diet, occlusal forces), reducing inter-patient variability.
Study Design Type: Prospective, randomized, split-mouth trial
Population: 20 patients (ages ≥12 years) with permanent dentition undergoing fixed orthodontic treatment
Follow-up duration: 12 months post-bonding
Setting: University-based orthodontic clinic
Interventions Test Adhesive (Experimental): A commercially available etch-free adhesive system applied directly to enamel without acid etching or separate priming.
Control Adhesive: Conventional orthodontic adhesive applied following 37% phosphoric acid etching, primer, and adhesive placement.
Randomization and Bonding Procedure Each patient will receive both adhesives-one on the left side and one on the right-randomly assigned using a computer-generated randomization schedule and sealed envelopes.
Bonding will be performed by a calibrated operator using identical brackets and bonding techniques.
Control side: 37% phosphoric acid etch (30 seconds), rinse, dry, primer, and adhesive.
Experimental side: Etch-free adhesive applied directly per manufacturer instructions.
Bonding time for each side will be measured with a stopwatch.
Sample Size Justification Twenty patients will contribute approximately 212 bonded brackets (10-12 per side, excluding molars and second premolars). This sample size provides 80% power to detect a clinically meaningful difference in bond failure rates (expected 5% failure rate for the etch-free adhesive vs. 10% for conventional adhesive; α = 0.05), analyzed using McNemar's test for paired binary outcomes.
Outcome Measures Primary Outcome
Bracket Failure Rate: Number and location of dislodged brackets on test vs. control sides recorded at monthly visits.
Secondary Outcomes
Bonding Time: Measured in seconds per side.
Enamel Condition at Debonding: Assessed clinically and photographically by blinded evaluators.
Adhesive Remnant Index (ARI): Scored 0-3 after debonding.
White Spot Lesions (WSLs): Presence and severity assessed clinically and photographically at baseline and after 12 months using standardized scoring.
Patient-Reported Outcomes (if applicable): Discomfort related to bonding/debonding.
Data Collection and Management Data will be recorded using standardized forms and stored on secure, encrypted institutional servers.
Clinical photographs will document enamel condition and WSLs.
All data will be coded and de-identified. Only authorized study personnel will have access.
Ethical Considerations The study has been reviewed by the University of Maryland Institutional Review Board (IRB #HP-00115604) and determined to be minimal risk.
Written informed consent will be obtained from adult participants; minors will provide assent with parental consent.
Both adhesives are commercially available and widely used in clinical practice; no experimental drugs or devices are involved.
No additional radiographs or invasive procedures are required beyond standard care.
Participants may withdraw at any time without affecting their ongoing treatment.
This trial seeks to determine whether an etch-free adhesive can reduce enamel damage and improve bonding efficiency without compromising clinical performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| Etch-Free Adhesive | Experimental | Device: Etch-Free AdhesiveTeeth on one randomized side of the mouth will be bonded with a novel self-adhesive orthodontic material that does not require prior acid etching or primer application. |
| Conventional Etch-and-Bond Adhesive | Experimental | Device: Conventional Etch-and-Bond AdhesiveTeeth on the contralateral side of the mouth will be bonded using the standard orthodontic bonding protocol with 35-37% phosphoric acid etching, primer, and conventional resin adhesive. |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients aged 14 to 35 years
- Requiring comprehensive fixed orthodontic treatment with brackets on both arches
- Good general health with no contraindications to orthodontic treatment
- Presence of at least 10 permanent teeth per arch suitable for bracket bonding
- Ability and willingness to comply with study visits and follow-up for at least 12 months
Key exclusion criteria (8 listed)
- Presence of systemic diseases or conditions that affect oral health or healing (e.g., uncontrolled diabetes, immunosuppression)
- Teeth with significant enamel defects, restorations, or caries in bonding areas
- Patients currently undergoing or who have undergone orthodontic treatment previously
- History of allergy or sensitivity to dental adhesives or related materials
- Patients with poor oral hygiene or active periodontal disease
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 |
|---|---|---|
| Etch-Free AdhesiveA self-adhesive orthodontic bonding material applied directly to enamel without prior phosphoric acid etching or primer application. Brackets are bonded following the manufacturer's instructions. | Device | Etch-Free Adhesive |
| Conventional Etch-and-Bond AdhesiveA standard orthodontic bonding protocol using 35-37% phosphoric acid etching, primer application, and a conventional light-cure adhesive. Brackets are bonded following the manufacturer's recommended procedure. | Device | Conventional Etch-and-Bond Adhesive |
Primary outcome
Bracket Failure Rate
Time frame: Through study completion, up to 12 months post-bonding (evaluated at each routine orthodontic visit).
The proportion of brackets bonded with each adhesive (etch-free vs. conventional) that experience bond failure over a 12-month follow-up period. A bond failure is defined as a clinically detached bracket requiring rebonding.
4 secondary outcomes
Bonding Time Per Quadrant
Time frame: At the initial bonding appointment (Day 1).
Adhesive Remnant Index (ARI) at Debonding
Time frame: At debonding (approximately 12 months post-bonding or at completion of treatment).
Enamel Surface Integrity
Time frame: At debonding (approximately 12 months post-bonding).
White Spot Lesion (WSL) Formation
Time frame: At baseline (Day 1), 6 months, and 12 months post-bonding.
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 10 Nov 2025.
- Individual participant dataSharing planned: No. This study involves minimal-risk clinical data and will be reported in aggregate form only. De-identified individual participant data will not be shared outside the study team.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etch-Free Adhesive and Conventional Etch-and-Bond Adhesive in people with Bracket Bonding and Orthodontic Treatment, run by University of Maryland, Baltimore at 1 site in United States.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Nov 2025. 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 United States. 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?
Contact Flavio Copello, DDS, MS, PhD (4108043239, fcopello@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bracket Failure Rate (time frame: Through study completion, up to 12 months post-bonding (evaluated at each routine orthodontic visit).). 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 10 Nov 2025; AzTrials last refreshed its copy on 31 Oct 2026.