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Clinical Trial of New Etch-Free Orthodontic Adhesive's Bond Failure Rate

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Study AimThis study looks at the failure rate of a new etch-free orthodontic adhesive, comparing it to traditional adhesives. By tracking how many brackets become detached over a year, we can see if the new adhesive is as effective in keeping brackets in place.
What is being tested

Etch-Free Adhesive

+ Conventional Etch-and-Bond Adhesive
Device
Who is being recruted

From 14 to 35 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorUniversity of Maryland, Baltimore
Study ContactFlavio Copello, DDS, MS, PhD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 5, 2025Actual date on which the first participant was enrolled.

This clinical trial focuses on evaluating a new type of orthodontic adhesive that doesn't require the traditional acid etching process. Typically, acid etching is used to help adhesives stick to teeth, but it can damage tooth enamel and make teeth more prone to developing white spots. The new adhesive aims to bond directly to the tooth surface without this step, potentially preserving the enamel and making the application process quicker and more comfortable for patients. The study involves 20 patients, aged 12 and older, who are receiving fixed orthodontic treatment, and it seeks to determine if this new method can maintain strong dental bonds without the drawbacks of enamel damage. In this study, each participant will have both the traditional and the new etch-free adhesive applied to different sides of their mouth, allowing direct comparison under the same oral conditions. The bonding process involves applying the traditional adhesive after etching the teeth with phosphoric acid on one side, while the new adhesive is applied directly on the other side. The primary focus is on the rate at which brackets fail or fall off, and this will be checked monthly. Other aspects being measured include the time taken to bond each bracket, the condition of the enamel after the brackets are removed, and any discomfort reported by patients. The study ensures participants' safety and confidentiality, with the trial being reviewed for minimal risk and allowing participants to withdraw anytime without affecting their treatment.

Official TitleA Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive 
NCT07091422
Principal SponsorUniversity of Maryland, Baltimore
Study ContactFlavio Copello, DDS, MS, PhD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 14 to 35 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.

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.
Group II
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.

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 Objectives
Primary Objectives

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.
Secondary Objectives

The time required to bond all brackets in one quadrant using either adhesive, measured in minutes using a digital timer.

The amount of adhesive remaining on the tooth surface after bracket removal, scored using the standardized Adhesive Remnant Index (0-3 scale).

Visual assessment of enamel for cracks, roughness, or damage after bracket removal, evaluated through clinical inspection and standardized digital photographs.

Incidence and severity of new white spot lesions on bonded teeth, assessed using a standardized WSL index at 6 and 12 months.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
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University of Maryland Baltimore School of DentistryBaltimore, United StatesSee the location
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One Study Center