Clinical trial NCT05573308: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusion
Misaligned Teeth
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: American Association of Orthodontists Foundation
First posted: 2022-10-10
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Primary outcomes:
measure: The number of aligners trays completed with an adequate fit
timeFrame: 6 to 30 months
measure: Number of refinements plans
timeFrame: 6 to 30 months
measure: Number of refinement aligners
timeFrame: 6 to 30 months
measure: The ratio of added trays(refinement)/planned trays.
timeFrame: 6 to 30 months
Secondary outcomes:
measure: ABO Discrepancy Index
timeFrame: 6 to 30 months
measure: The American Board of Orthodontics (ABO) Objective grading system (OGS)
timeFrame: 6 to 30 months
measure: Degree of tooth movement
timeFrame: 6 to 30 months
Other outcomes:
measure: Number of office visits
timeFrame: 6 to 30 months
measure: Patient compliance
timeFrame: 6 to 30 months
Locations:
city: Antioch
country: United States
facility: Orthodontic Specialists of Lake County (Antioch)
state: Illinois
city: Chicago
country: United States
facility: Department of Orthodontics, College of Dentistry University of Illinois Chicago
state: Illinois
city: Grayslake
country: United States
facility: Orthodontic Specialists of Lake County (Grayslake)
state: Illinois
city: Gurnee
country: United States
facility: Orthodontic Specialists of Lake County (Gurnee)
state: Illinois
Study officials:
References:
citation: 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.