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

University of Illinois

Status: Enrolling

Conditions: Misaligned Teeth; Malocclusion

Treatments: Device: Clear Aligners with Dental Monitoring; Device: Clear Aligners

Study type: Interventional

Funder types: Other

Identifiers

NCT05573308

Protocol # 2021-0644

Details and patient eligibility

About

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.

Full description

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

Enrollment: 12 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 3 patient groups

Clear Aligners with Dental Monitoring

Experimental group

Description:

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.

Treatment:

Device: Clear Aligners with Dental Monitoring

Clear Aligners replaced every 7 days

Active Comparator group

Description:

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.

Treatment:

Device: Clear Aligners

Clear Aligners replaced every 14 days

Active Comparator group

Description:

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.

Treatment:

Device: Clear Aligners