Etch-Free Adhesive for Bracket Bonding

Overseen By Flavio Copello, DDS, MS, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Corticosteroids

Disqualifiers: Diabetes, Immunosuppression, Poor oral hygiene, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new adhesive for braces that doesn't require acid etching, which can harm tooth enamel. The goal is to determine if this etch-free adhesive is as effective as the traditional method while being safer for teeth. Individuals beginning treatment with braces and having at least 10 permanent teeth per arch might be suitable candidates. Researchers will treat one side of each participant's mouth with the new adhesive and the other with the conventional method to compare results. The study will monitor outcomes over 12 months, focusing on bracket stability and enamel health. As an unphased trial, this study offers a unique opportunity to contribute to dental innovation and potentially benefit from a safer adhesive option.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using medications that affect tooth enamel or oral tissues, you may not be eligible to participate.

What prior data suggests that this etch-free adhesive is safe for orthodontic patients?

In a previous study, researchers examined a special adhesive for attaching braces that eliminates the usual acid etching process. This is significant because acid etching can sometimes damage tooth enamel. The study found that this new adhesive protected enamel and performed well even in moist conditions, reducing the chances of braces coming loose.

No specific negative side effects were reported from using this adhesive. As this is an early study, the focus remains on ensuring the product's effectiveness and safety for teeth. If the adhesive continues to perform well, it could offer a safer option for attaching braces without risking enamel damage from acid etching. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Etch-Free Adhesive for bracket bonding because it simplifies the bonding process by eliminating the need for acid etching and primer application. Traditional methods require multiple steps, including etching with phosphoric acid and applying a primer, which can be time-consuming and increase the risk of errors. This new adhesive acts as a self-adhesive material, streamlining the bonding process and potentially reducing chair time for both orthodontists and patients. By simplifying the procedure, the Etch-Free Adhesive could make orthodontic treatments more efficient and comfortable.

What evidence suggests that this etch-free adhesive is effective for bracket bonding?

This trial will compare an Etch-Free Adhesive with a Conventional Etch-and-Bond Adhesive for bracket bonding. Research has shown that the new Etch-Free Adhesive can protect tooth enamel without acid etching. This adhesive adheres well even in a wet mouth, a common challenge. Although there is a slightly higher chance of brackets coming loose (6.3%) with this adhesive compared to traditional methods, its overall performance remains promising. The main advantage is its ability to reduce the risk of enamel damage and white spots, concerns associated with acid etching. This makes it a potentially safer and more efficient choice for attaching orthodontic brackets. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for orthodontic patients aged 14-35 needing braces on both arches, with at least 10 permanent teeth per arch suitable for bonding. They must be in good health and able to follow the study for 12 months. Parental consent is required for minors.

Inclusion Criteria

I can attend all study visits for the next 12 months.

I (or my child) have given consent to participate.

I have at least 10 permanent teeth per arch that can have braces attached.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orthodontic bonding with either etch-free or conventional adhesive on different sides of the mouth

1 day

1 visit (in-person)

Follow-up

Participants are monitored for bracket failure, enamel condition, and white spot lesions

12 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Etch-Free Adhesive

Trial Overview The trial compares a new etch-free adhesive against a conventional acid-etching method used in orthodontics. Each patient's mouth will have one side treated with each type of adhesive, allowing direct comparison under the same oral conditions.

How Is the Trial Designed?

Group I: Etch-Free Adhesive Experimental Treatment 1 Intervention

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.

Group II: Conventional Etch-and-Bond Adhesive Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07091422

A Split-Mouth Clinical Trial Evaluating the Bond Failure ... If effective, the etch-free adhesive may reduce enamel damage without compromising bond strength, providing a safer and more efficient bonding option for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10462921/

Comparative evaluation of bracket bond failure rates of a ... An overall higher bracket failure rate (6.3%) was observed in teeth bonded with primerless adhesive than conventional adhesive. No significant individual teeth ...

3. patlynk.com patlynk.com/trial/NCT07091422

Clinical Trial of New Etch-Free Orthodontic Adhesive's ... 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 ...

4. ormco.com ormco.com/en-us/etchfree-bonding-solution

EtchFree Moisture Tolerant Bonding This technology allows EtchFree Bonding to help maintain the enamel health and completely withstand moisture contamination, reducing debonds compared to other ...

5. prnewswire.com prnewswire.com/news-releases/launch-of-ormco-etchfree-bonding-eliminates-acid-etching-302438076.html

LAUNCH OF ORMCO™ ETCHFREE BONDING ... Ormco EtchFree Bonding exhibits consistent bond strength under dry or wet conditions (vs. tested products). Etchfree Bonding has fewer debonds ...

6. ormco.com ormco.com/en-us/safety-data-sheets

Ormco's Safety Data Sheets for your Information Ormco presents it's easy to use library of Safety Data Sheets and Guides for your practice. Browse by Document and Product. Many languages are available.

7. orthopracticeus.com orthopracticeus.com/breaking-the-bonding-barrier-a-new-era-with-ormco-etchfree-bonding/

Ormco Etch-Free Bonding — clinical precision and patient ... Ormco Etch-Free Bonding brings better bond strength, adhesive thickness, and adhesive cure.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9863063/

Effect of Different Types of Adhesive Agents on Orthodontic ... The aim of this study was to evaluate the shear bond strength of brackets bonded to teeth etched with a conventional acid etching method in a laboratory ...