Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms

Study Overview
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Brief Summary
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The decision on aligner changing is based on orthodontists' personal experience and common knowledge that an approximated time span for the aligner have exhausted its biological efficacy. However, a one size fits all approach is not always ideal, as an average determined time is not taken into account of a patient's individual biological response. The aligners could be progressed earlier than the determined time, or they may stay inactive for a while, waiting for the in-office visit. Dental MonitoringTM is the only available technology that provides 3D monitoring of teeth movement, reconstructs 3D digital models remotely, and auto-detect clinical situations by their patented AI algorithms. The investigators have reported high accuracy of DMTM to monitor the tooth movement in vitro. However, the efficacy of DMTM on orthodontic treatment and the accuracy of DMTM in the orthodontic patients has not been investigated yet. In this proposal, the investigators are implementing the Dental MonitoringTM application and 3D tracking of tooth movement powered by AI algorisms as a novel tool to customize aligner changing intervals. The ultimate goal is to reduce in-office visits and treatment duration while maintaining regular monitoring, thus not jeopardizing expected results. It is imperative to investigate the Teledentistry for its effectiveness, reliability, ease of use, patient satisfaction, and value on the overall health and oral health system, especially as a critical tool during public health emergency situations.

Detailed Description
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Specific Aims Clear Aligners: To evaluate the effects of implementing Remote Dental Monitoring in orthodontic treatment with clear Aligners. The outcome measures are treatment effectiveness, rate of aligner changing, number of refinements (ratio of added Aligners/planned Aligners- need for midcourse correction), number of appointments, Cost-effectiveness, and patient satisfaction. Hypothesis 1: Remote Dental Monitoring provides a viable option for continuing good quality of care without compromising the treatment outcome and satisfaction. There are no differences in treatment quality, value, effectiveness, and safety between Remote Dental Monitoring and in-office treatment approaches. Hypothesis 2: Remote Dental Monitoring can guide the rate of aligner replacement and optimize the treatment. Hypothesis 3: Remote Dental Monitoring can Improve patient compliance and motivate patients' oral hygiene maintenance

Official Title
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Optimizing Clear Aligners Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms

Conditions
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Malocclusion, Misaligned Teeth

Intervention / Treatment
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* Device: Clear Aligners with Dental Monitoring
* Device: Clear Aligners


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who request clear aligner treatment with the sole aim of correcting dental alignment. Patients must be 12 years old or older. Complete permanent dentition (excluding third molars). Non-extraction treatment, Upper or lower labial segment crowding. malocclusion to be treated with more than 20 Clear Aligners. Exclusion Criteria: Patients with systematic diseases or syndromes Patients with a history or current use of Bisphosphonates Patients with current use of nonsteroidal anti-inflammatory drugs (NSAIDs) Active periodontal disease Presence of dental prostheses, The presence of dental anomalies (7) The treatment combined with fixed appliances or other auxiliary appliances.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clear Aligners with Dental Monitoring<br>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. | Device: Clear Aligners with Dental Monitoring<br>* Dental Monitoring™ (DM ™). This digital technology software allows orthodontists to monitor patients remotely through continuous analytics using control vision technology, metaheuristics, and artificial intelligence.31 This app utilizes a patented artificial intelligence machine learning algorithm to calculate 3-dimensional (3D) tooth movements from intraoral photos and videos that patients capture using their smartphone cameras.<br>|
| Active Comparator: Clear Aligners replaced every 7 days<br>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. | Device: Clear Aligners<br>* Removabale orthodontics appliances<br>|
| Active Comparator: Clear Aligners replaced every 14 days<br>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. | Device: Clear Aligners<br>* Removabale orthodontics appliances<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of aligners trays completed with an adequate fit | The primary outcome, the number of trays completed with an adequate fit after 6, 12 months and end of treatment (treatment length ranged 18-30) months. | 6 to 30 months | 
| Number of refinements plans |  | 6 to 30 months | 
| Number of refinement aligners |  | 6 to 30 months | 
| The ratio of added trays(refinement)/planned trays. |  | 6 to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABO Discrepancy Index | The higher the ABO DI score, the more complex the case. Therefore with treatment progress, the DI Score should Decrease at least 1 point from the ABO DI score before treatment. | 6 to 30 months | 
| The American Board of Orthodontics (ABO) Objective grading system (OGS) | The ABO score for the case is calculated by summing the scores for the 8 categories. The casts are scored in 7 categories (alignment, marginal ridges, buccolingual inclinations, occlusal relationships, occlusal contacts, overjet, and interproximal contacts), and panoramic radiographs are scored according to the single category of root angulation. If fewer than 20 points are scored overall, the case is considered to meet the ABO standard. If 20 to 29 points are scored, then the standard of work is undetermined. If more than 30 points are scored, the case is considered unacceptable. | 6 to 30 months | 
| Degree of tooth movement | 3D Comparison Analysis will be performed to evaluate the treatment progress using a sophisticated processing software package (Control; Geomagic, Research Triangle Park, NC). Furthermore, each 3D digital dental scan at T3 will be superimposed on the 3D Digital model of the corresponding treatment stage in the aligner software (representing the ideal outcome).To determine the degree of tooth movement achieved with respect to the prescription, the following formula will be applied to each movement of each tooth. 1-(Ideal outcome-treatment outcome)/(Ideal outcome- Pre-treatment) | 6 to 30 months |