AI-Powered Remote Dental Monitoring for Misaligned Teeth

Recruiting at 3 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Bisphosphonates, NSAIDs

Disqualifiers: Systematic diseases, Active periodontal disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 to 30 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if AI-powered remote monitoring can enhance the timing and effectiveness of clear aligner treatments for misaligned teeth. Instead of adhering to a fixed schedule for changing aligners, the study tests a method that customizes timing based on real-time monitoring of tooth movement. Participants will be divided into groups: some will use the new AI system, while others will follow traditional schedules of changing aligners every 7 or 14 days. Prospective participants should seek clear aligner treatment to correct dental alignment without extractions and have more than 20 aligners in their treatment plan. As an unphased trial, this study provides a unique opportunity to explore innovative dental treatment methods.

Will I have to stop taking my current medications?

The trial requires that you do not use nonsteroidal anti-inflammatory drugs (NSAIDs) during participation. If you are currently using NSAIDs, you will need to stop taking them to be eligible for the trial.

What prior data suggests that this remote dental monitoring technique is safe for orthodontic patients?

Research has shown that AI-powered remote dental monitoring is generally well-received by patients. This technology accurately tracks tooth movement using 3D digital models. Patients scan their teeth with a smartphone, enabling orthodontists to check progress remotely.

Few reports have indicated any negative effects or safety concerns with this technology. The main focus has been on its effectiveness and accuracy in monitoring teeth. Since this trial is in the "Not Applicable" phase, the technology is still being tested for effectiveness and safety. However, other studies and situations have not revealed major safety issues, suggesting it is likely safe for use in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AI-powered remote dental monitoring for misaligned teeth because it introduces a digital twist to traditional orthodontic treatments. Unlike conventional methods where aligners are routinely replaced every 7 or 14 days with regular in-office visits, this approach uses advanced 3D digital scans and smartphone technology to track tooth movement remotely. This means patients can potentially have their aligners adjusted in real-time, based on precise AI analysis, reducing the need for frequent office visits and personalizing the treatment process. The integration of AI and remote monitoring aims to make orthodontic care more efficient and convenient, potentially transforming how we approach dental alignment.

What evidence suggests that this trial's treatments could be effective for misaligned teeth?

This trial will compare different approaches to using clear aligners for orthodontic treatment. One arm of the trial will use AI-powered Remote Dental Monitoring. Research has shown that this technology can make orthodontic treatments more precise. AI systems analyze large amounts of data to adjust aligners based on tooth movement. Studies have found that this technology can diagnose and manage crooked teeth more accurately and efficiently. Early results suggest that AI tools like Dental MonitoringTM can create personalized treatment plans, potentially reducing the number of dentist visits. Overall, this method aims to align teeth effectively while saving time and maintaining high-quality treatment. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with misaligned teeth or malocclusion who need more than 20 clear aligners and are at least 12 years old with all permanent teeth (except wisdom teeth). They should want to correct dental alignment without extractions. It's not for those with gum disease, a history of certain bone treatments, dental prostheses, tooth anomalies, other appliance use, systemic diseases or syndromes, or current NSAID users.

Inclusion Criteria

I need treatment for crowded teeth requiring over 20 clear aligners.

I am 12 years old or older.

My treatment does not involve surgical removal.

Exclusion Criteria

Presence of dental anomalies

Presence of dental prostheses

My treatment involves braces or other supportive devices.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orthodontic treatment with clear aligners, monitored remotely using Dental Monitoring technology. Aligners are replaced every 7 or 14 days based on the group assignment.

6 to 30 months

Standard in-office visits every 8 weeks

Follow-up

Participants are monitored for treatment effectiveness, patient satisfaction, and compliance using remote dental monitoring and in-office assessments.

6 to 30 months

What Are the Treatments Tested in This Trial?

Interventions

• Optimizing Orthodontic Appliances Efficiency

Trial Overview

The study tests if using Dental MonitoringTM technology along with AI algorithms can better customize the timing of changing clear aligners compared to standard practices. The goal is to potentially reduce office visits and overall treatment time while still closely monitoring progress remotely during orthodontic treatment.

How Is the Trial Designed?

Group I: Clear Aligners with Dental Monitoring Experimental Treatment 1 Intervention

Experiment group: DM (Remote Dental Monitoring approach). Remote Dental Monitoring by DMTM will be implemented in the patient's orthodontic treatment. Pretreatment, 3D digital intra-oral scans will be uploaded to the DMTM dashboard, so they serve as the baseline for 3D tracking of tooth movement. Patients will be trained on how to use the DMTM application and do DM remote scans using their smartphones DM scan box and rector. They will be instructed to do the DM scan after the initial tray insertion. Replacement of the aligners trays will be based on DM GO tracking function, which is specifically targeted at clear aligner treatment.

Group II: Clear Aligners replaced every 7 days Active Control 1 Intervention

Group 2:Control group. All subjects will have conventional aligner treatment with aligners replaced every 7 days, and standard in-office visits every 8 weeks.

Group III: Clear Aligners replaced every 14 days Active Control 1 Intervention

Group 3: (n=40) Control group. All subjects will have conventional aligner treatment with aligners replaced every 14 days, and standard in-office visits every 8 weeks.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Mohammed H Elnagar

Lead Sponsor

Trials

1

Recruited

10+

American Association of Orthodontists Foundation

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

The study evaluated the accuracy of 3D digital models generated by the Dental Monitoring (DM) application against those created by the iTero Element 5D intraoral scanner in 24 patients over an average of 13.4 months during orthodontic treatment.

Results showed no clinically significant difference between the two methods, indicating that the DM application can effectively track tooth movement and create reliable 3D models for orthodontic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-vivo evaluation of Artificial Intelligence Driven Remote Monitoring technology for tracking tooth movement and reconstruction of 3-dimensional digital models during orthodontic treatment. Homsi, K., Snider, V., Kusnoto, B., et al.[2023]

The use of a remote digital monitoring system (Dental Monitoring®) during the retention phase of orthodontic treatment significantly reduced the occurrence of misfit of removable retainers in a study of 27 patients.

While the remote monitoring did not significantly affect the number of emergency appointments or changes in intercanine width, these preliminary findings suggest that such technologies could be beneficial, especially during times when in-office visits are challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote digital monitoring during the retention phase of orthodontic treatment: A prospective feasibility study. Sangalli, L., Savoldi, F., Dalessandri, D., et al.[2022]

In a study evaluating four virtual assistants (Google Assistant, Siri, Alexa, and Cortana) for answering orthodontic questions, Google Assistant performed the best, indicating it may be the most efficient tool for patient inquiries in orthodontic settings.

The study highlighted significant variability in the performance of these virtual assistants, suggesting that a tailored virtual assistant with evidence-based orthodontic responses could greatly enhance patient and clinician interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of artificial intelligence-based virtual assistants in responding to routinely asked questions about orthodontics. Perez-Pino, A., Yadav, S., Upadhyay, M., et al.[2023]

The study involved 49 orthodontic patients, with the DM group (24 patients) monitored for 13 months and the control group (25 patients) for 5 months, showing that the DM group had significantly better oral hygiene as indicated by lower Plaque Index (OPI) and Modified Gingival Index (MGI) scores.

The use of AI-driven personalized notifications through Dental Monitoring™ effectively improved oral hygiene over time, particularly noticeable after the initial 3 months of treatment, suggesting that regular monitoring can help maintain better oral health during orthodontic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of AI-driven remote monitoring technology in improving oral hygiene during orthodontic treatment. Snider, V., Homsi, K., Kusnoto, B., et al.[2023]

In a study of 60 patients comparing Invisalign and fixed orthodontic appliances, it was found that fixed appliances resulted in significantly greater movement of maxillary incisors and canines in all directions, particularly in rotation and tipping of the canines.

Despite the differences in tooth movement, the overall quality of treatment outcomes, as measured by Peer Assessment Rating scores, was similar for both Invisalign and fixed appliances, indicating that both methods can achieve comparable results in orthodontic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maxillary anterior tooth movement between Invisalign and fixed appliances. Murphy, SJ., Lee, S., Scharm, JC., et al.[2023]

A scoping review of 62 studies indicates a significant rise in the use of artificial intelligence (AI) and machine learning (ML) in orthodontics, particularly in diagnosis and treatment planning, with 69% of studies published in the last decade.

Artificial Neural Networks (ANNs) were the most frequently used algorithms, highlighting the growing integration of advanced technology in orthodontic practices, although challenges remain in translating these findings into clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of artificial intelligence and machine learning in orthodontics: a scoping review. Bichu, YM., Hansa, I., Bichu, AY., et al.[2023]

The study involving 30 patients using a smartphone application for remote monitoring of clear aligner therapy found that only 83.3% of instructions were consistent between two scans, raising concerns about the reliability of AI-generated treatment guidance.

Significant discrepancies in tooth positioning were observed in patients receiving both 'GO' and 'NO-GO' instructions, indicating that the AI's decisions may not align with actual measurements, which could impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of artificial intelligence-based remote monitoring of clear aligner therapy: A prospective study. Ferlito, T., Hsiou, D., Hargett, K., et al.[2023]

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