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

Official title

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

Overview

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

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

Interventions

• Device Clear Aligners with Dental Monitoring
  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.
• Device Clear Aligners
  Removabale orthodontics appliances

Primary outcome measures

• The number of aligners trays completed with an adequate fit [Time frame: 6 to 30 months]
• Number of refinements plans [Time frame: 6 to 30 months]
• Number of refinement aligners [Time frame: 6 to 30 months]
• The ratio of added trays(refinement)/planned trays. [Time frame: 6 to 30 months]

Secondary outcome measures (3)

• ABO Discrepancy Index [Time frame: 6 to 30 months]
• The American Board of Orthodontics (ABO) Objective grading system (OGS) [Time frame: 6 to 30 months]
• Degree of tooth movement [Time frame: 6 to 30 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Orthodontic Specialists of Lake County (Antioch) — Antioch
• Department of Orthodontics, College of Dentistry University of Illinois Chicago — Chicago
• Orthodontic Specialists of Lake County (Grayslake) — Grayslake
• Orthodontic Specialists of Lake County (Gurnee) — Gurnee

Publications

• Morris RS, Hoye LN, Elnagar MH, Atsawasuwan P, Galang-Boquiren MT, Caplin J, Viana GC, Obrez A, Kusnoto B. Accuracy of Dental Monitoring 3D digital dental models using photograph and video mode. Am J Orthod Dentofacial Orthop. 2019 Sep;156(3):420-428. doi: 10.1016/j.ajodo.2019.02.014. PMID 31474272

Identifiers

NCT: NCT05573308 · Protocol # 2021-0644

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗