Digital Bonding vs. Direct Bonding for Orthodontic Brackets

Recruiting at 5 trial locations

Overseen By Helen Han

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Solventum Orthodontics Corporation

Disqualifiers: Pregnancy, Breastfeeding, Advanced periodontal disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18-24 months

178 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Digital Bonding vs. Direct Bonding for Orthodontic Brackets?

Research shows that indirect bonding, which is part of digital bonding, can reduce the time spent in the dentist's chair and improve the accuracy of bracket placement compared to direct bonding. Additionally, newer adhesives used in indirect bonding have increased clinical success, making it a favorable option for orthodontic treatment. ^{1 2 3 4 5}

Is orthodontic bracket bonding safe for humans?

Direct bonding of brackets onto teeth can have some side effects, mainly affecting the enamel, especially if there are pre-existing white spots. However, the risk of damage is limited when the etching agent is applied carefully. ^{1 4 6 7 8}

What makes the Digital Bonding treatment unique compared to other orthodontic bonding methods?

Digital Bonding, also known as indirect bonding, is unique because it reduces the time spent in the dental chair and allows for more accurate placement of brackets on study models rather than directly in the mouth. This method overcomes common issues with indirect bonding, such as inconsistent adhesion and excess composite, by using a simplified bonding technique. ^{4 8 9 10 11}

Research Team

Lori Leitheiser

Principal Investigator

Solventum Orthodontics Corporation

Eligibility Criteria

This trial is for individuals aged 12 or older who need comprehensive orthodontic treatment with brackets on both arches, have mild to moderate teeth crowding, and a specific range of overbite. They must not be pregnant or breastfeeding, have advanced gum disease, non-movable teeth like implants, or severe enamel abnormalities.

Inclusion Criteria

The Subject's intra-oral scan must have been taken within 90 days of bracket placement

The Subject is anticipated to complete treatment within 18 to 24 months

Subject has an overbite measuring between -1 mm (open bite) and 5 mm (deep bite)

Exclusion Criteria

Subject is pregnant or breast feeding

Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria

I have severe gum disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either digital bonding or direct bonding treatment for bracket placement

18-24 months

Initial bonding visit, multiple adjustment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Digital Bonding
• Direct Bonding

Trial Overview The study is testing if using digital bonding trays to place orthodontic brackets is more efficient than the traditional direct method. Participants are randomly assigned to one of these two methods in this forward-looking multi-site trial.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Digital Bonding Tray. Brackets will be bonded to each subject's teeth with a digital bonding tray.

Group II: Control Group Active Control 1 Intervention

Direct bonding method. Brackets will be bonded to each subject's teeth by direct placement.

Digital Bonding is already approved in United States, European Union, Canada for the following indications:

Approved in United States as 3M Digital Bonding for:

• Orthodontic treatment for malocclusions
• Dental alignment

Approved in European Union as 3M Digital Bonding for:

• Orthodontic treatment for malocclusions
• Dental alignment

Approved in Canada as 3M Digital Bonding for:

• Orthodontic treatment for malocclusions
• Dental alignment

Who Is Running the Clinical Trial?

Solventum Orthodontics Corporation

Lead Sponsor

Trials

2

Recruited

230+

3M

Lead Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania

Findings from Research

In a systematic review of 7 randomized clinical trials involving orthodontic bracket bonding techniques, the direct bonding method showed a significantly lower failure rate compared to the indirect method over a long-term follow-up of 12-15 months.

During the initial 0-6 month period, both bonding techniques had similar adhesion failure rates, indicating that the advantages of direct bonding become more apparent over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthodontic bracket bonding techniques and adhesion failures: A systematic review and meta-analysis. Dos Santos, AL., Wambier, LM., Wambier, DS., et al.[2022]

Virtual bonding of orthodontic attachments is more accurate than direct bonding, particularly in vertical and horizontal dimensions, based on a study involving 1120 artificial teeth across four groups of clinicians with varying experience.

Experienced clinicians showed greater accuracy in virtual bonding compared to postgraduate students, especially in the angular dimension, highlighting the importance of clinical experience in achieving precise orthodontic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of clinical experience on accuracy of virtual orthodontic attachment bonding in comparison with the direct procedure. De Oliveira, NS., Rossouw, E., Lages, EMB., et al.[2021]

Recent advancements in adhesives for indirect bonding of orthodontic brackets have significantly improved clinical success rates for orthodontists.

The article reviews various techniques and procedures that highlight the advantages of indirect bonding over direct bonding, suggesting it is a worthwhile method for dental practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect bonding of brackets: don't wait another day! Pellan, P.[2021]

Using a 3D printing pen to create transfer trays from polylactic acid (PLA) for indirect orthodontic bonding significantly reduces chairside time compared to direct bonding methods.

The PLA transfer trays provide precise bracket positioning and allow for effective light curing, leading to improved bond reliability and efficiency in the orthodontic bonding process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D Printing Pen: A Novel Adjunct for Indirect Bonding. Kulkarni, NB., Goyal, SM., Shah, VD.[2021]

In a study involving 19 sets of Class II malocclusion models, both direct and indirect bonding techniques for bracket placement were found to be inaccurate compared to ideal placements.

Indirect bonding generally resulted in better bracket height accuracy, while direct bonding performed better in angulation for specific teeth, indicating that while neither method achieved perfect placement, indirect bonding may have advantages in certain aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the accuracy of bracket placement between direct and indirect bonding techniques. Koo, BC., Chung, CH., Vanarsdall, RL.[2022]

Direct bonding of brackets to tooth enamel is a common orthodontic practice, but it can lead to negative side effects, particularly in the presence of pre-existing white spots on the enamel.

Careful application of the etching agent during the bonding process can minimize the risk of enamel damage, highlighting the importance of technique in orthodontic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of acid etchants in orthodontics]. Hummel, GI., van Koldam, FA., Dibbets, JM.[2006]

Both second- and third-generation LED light-curing units (LCUs) provided strong bond strengths for dental brackets, exceeding acceptable clinical levels, with no significant differences in effectiveness between the two generations.

While the bonding effects were similar, the second-generation LCUs had shorter curing times compared to the third-generation units, suggesting a potential advantage in efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the bonding strengths of second- and third-generation light-emitting diode light-curing units. Lee, HM., Kim, SC., Kang, KH., et al.[2020]

A systematic review of 8 randomized controlled trials involving 247 orthodontic patients found no significant differences in bracket placement accuracy, oral hygiene status, or bond failure rates between direct and indirect bonding techniques.

Indirect bonding may save chairside time during procedures but requires more total working time compared to direct bonding, indicating a potential trade-off in efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, efficiency and adverse effects of using direct or indirect bonding technique in orthodontic patients: a systematic review and meta-analysis. Li, Y., Mei, L., Wei, J., et al.[2020]

The study compared two orthodontic bonding methods using 48 incisor and 48 premolar extracted human teeth, focusing on the effectiveness of a highly filled bis-GMA adhesive.

Results showed differences in tensile and shear bond strengths between the direct and indirect bonding methods, providing insights into which technique may offer better attachment for orthodontic brackets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bond strength comparison: a simplified indirect technique versus direct placement of brackets. Milne, JW., Andreasen, GF., Jakobsen, JR.[2019]

Indirect bonding of orthodontic brackets allows for more accurate placement compared to direct bonding, as it can be done on study casts rather than directly in the mouth.

A new simplified bonding method addresses common issues with indirect bonding, such as adhesion consistency and excess composite, while retaining the advantages of direct bonding techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The direct way of indirect bonding--the combined effect. Gayake, PV., Chitko, SS., Sutrave, N., et al.[2021]

In a study involving 54 extracted premolars, both indirect bonding with a new adhesive resin and direct bonding with a light-activated adhesive achieved mean shear bond strengths well above the clinical success threshold, indicating effective bonding methods.

There was no significant difference in shear bond strength between the two bonding techniques, suggesting that either method can be reliably used for orthodontic bracket placement without compromising effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear bond strength comparison between direct and indirect bonded orthodontic brackets. Yi, GK., Dunn, WJ., Taloumis, LJ.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Orthodontic bracket bonding techniques and adhesion failures: A systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of clinical experience on accuracy of virtual orthodontic attachment bonding in comparison with the direct procedure. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Indirect bonding of brackets: don't wait another day! [2021]

4. India pubmed.ncbi.nlm.nih.gov

3D Printing Pen: A Novel Adjunct for Indirect Bonding. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of the accuracy of bracket placement between direct and indirect bonding techniques. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

[Effects of acid etchants in orthodontics]. [2006]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of the bonding strengths of second- and third-generation light-emitting diode light-curing units. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness, efficiency and adverse effects of using direct or indirect bonding technique in orthodontic patients: a systematic review and meta-analysis. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Bond strength comparison: a simplified indirect technique versus direct placement of brackets. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The direct way of indirect bonding--the combined effect. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Shear bond strength comparison between direct and indirect bonded orthodontic brackets. [2022]