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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05573308
Other study ID # Protocol # 2021-0644
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 30, 2027

Study information

Verified date September 2022
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 30, 2027
Est. primary completion date December 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Clear Aligners
Removabale orthodontics appliances

Locations

Country Name City State
United States Orthodontic Specialists of Lake County (Antioch) Antioch Illinois
United States Department of Orthodontics, College of Dentistry University of Illinois Chicago Chicago Illinois
United States Orthodontic Specialists of Lake County (Grayslake) Grayslake Illinois
United States Orthodontic Specialists of Lake County (Gurnee) Gurnee Illinois

Sponsors (1)

Lead Sponsor Collaborator
Mohammed H Elnagar

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Number of office visits Number of office visits needed to finish the treatment 6 to 30 months
Other Patient compliance 6 to 30 months
Primary 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
Primary Number of refinements plans 6 to 30 months
Primary Number of refinement aligners 6 to 30 months
Primary The ratio of added trays(refinement)/planned trays. 6 to 30 months
Secondary 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
Secondary 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
Secondary 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
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