Recruiting

Orthodontic Appliances

Sponsor:

University of Illinois at Chicago

Code:

NCT05573308

Conditions

Malocclusion

Misaligned Teeth

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Accepted

Interventions

Clear Aligners with Dental Monitoring

Clear Aligners

Study Details

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.

Conditions

Malocclusion

Misaligned Teeth

Study ID

NCT05573308

Start date

Oct 17, 2022

Status verified date

May, 2026

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70

Healthy Volunteers: Accepted

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

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clear Aligners with Dental Monitoring

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.

active comparator: Clear Aligners replaced every 7 days

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.

active comparator: Clear Aligners replaced every 14 days

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.

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Department of Orthodontics, College of Dentistry University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612-7211

Contacts

Mohammed Elnagar, DDS, MS.PhD

312-996-7505melnagar@uic.edu

Lia Tahir, DDS

312-996-7505atahir3@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-08.