What side effects are associated with this type of intervention?

Common treatments for misaligned teeth, such as clear aligners, can have side effects including mild discomfort, soreness, and temporary speech difficulties. Some patients may experience gum irritation or dry mouth. Remote dental monitoring and AI algorithms, like those used in Dental MonitoringTM, aim to optimize treatment intervals and reduce in-office visits, but they may also introduce challenges such as reliance on patient compliance and potential technical issues with the monitoring system.

What prior FDA approvals exist?

The FDA has approved several treatments for misaligned teeth, including clear aligners such as Invisalign, which use a series of custom-made, removable aligners to gradually straighten teeth. These aligners are often paired with advanced technologies like 3D imaging to create precise treatment plans. While specific FDA approvals for systems incorporating AI algorithms for customized aligner changing intervals, like the Dental MonitoringTM being studied, are not detailed, the trend towards integrating digital monitoring and AI in orthodontics is evident. These innovations aim to enhance treatment efficiency and patient outcomes by allowing for more personalized and adaptive treatment adjustments.

What other types of research exist?

Promising alternatives to Dental MonitoringTM for misaligned teeth treatment in 2024 include: 1) SmartBracket systems, which use sensors embedded in braces to provide real-time data on tooth movement and pressure, allowing for precise adjustments. 2) AI-powered orthodontic apps that use machine learning to analyze patient photos and provide treatment recommendations and progress tracking. 3) Remote monitoring platforms that integrate with 3D imaging and telehealth services to offer continuous, personalized treatment adjustments without frequent in-office visits.

← Back to Search

Behavioural Intervention

AI-Powered Remote Dental Monitoring for Misaligned Teeth

N/A

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new technology called Dental MonitoringTM, which uses 3D images and artificial intelligence to track how teeth move. It aims to help people using clear aligners for orthodontic treatment by customizing when they should change their aligners. The goal is to reduce the need for frequent visits and shorten the overall treatment duration while still achieving good results. Dental Monitoring is a recently introduced orthodontic application that combines safe teledentistry with artificial intelligence (AI) using a knowledge-based algorithm, allowing accurate semi-automatic monitoring of the treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive technology rather than medication, traditional side effects aren't expected. However, there may be issues related to comfort and convenience when adapting to remote monitoring tools.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of aligners trays completed with an adequate fit

Secondary study objectives

ABO Discrepancy Index

Tooth structure

The American Board of Orthodontics (ABO) Objective grading system (OGS)

Other study objectives

Number of office visits

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Clear Aligners with Dental MonitoringExperimental Treatment1 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 daysActive Control1 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 daysActive Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Clear aligners, such as Invisalign, are a common treatment for misaligned teeth. They work by applying controlled forces to teeth, gradually moving them into the desired position. The use of 3D monitoring and AI algorithms, as seen in Dental MonitoringTM, enhances this process by providing precise tracking of tooth movement and allowing for customized aligner changing intervals. This ensures that the treatment is tailored to the individual’s biological response, potentially reducing treatment duration and the need for frequent in-office visits. For patients, this means a more efficient, effective, and convenient orthodontic experience.

A cone-beam computed tomographic study evaluating the efficacy of incisor movement with clear aligners: Assessment of incisor pure tipping, controlled tipping, translation, and torque.Spinal deformity and malocclusion association is not supported by high-quality studies: results from a systematic review of the literature.