MalocclusionNCT05573308
Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms
A study testing Clear Aligners with Dental Monitoring and Clear Aligners in people with Malocclusion and Misaligned Teeth, run by University of Illinois Chicago at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Misaligned Teeth
- What is being tested?
- Clear Aligners with Dental Monitoring and Clear Aligners
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Oct 2022to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 1 recruiting
- Suspended
Orthodontic Specialists of Lake County (Antioch)
Antioch, Illinois, 60002
- Recruiting
Department of Orthodontics, College of Dentistry University of Illinois Chicago
Chicago, Illinois, 60612-7211
Mohammed Elnagar, DDS, MS.PhD, 312-996-7505, melnagar@uic.edu
Lia Tahir, DDS, 312-996-7505, atahir3@uic.edu
- Suspended
Orthodontic Specialists of Lake County (Grayslake)
Grayslake, Illinois, 60030
- Suspended
Orthodontic Specialists of Lake County (Gurnee)
Gurnee, Illinois, 60031
About this study
Official title: Optimizing Clear Aligners Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms
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.
Read the 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
- Conditions
- Malocclusion, Misaligned Teeth
- Being tested
- Clear Aligners with Dental Monitoring, Clear Aligners
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Aligners with Dental MonitoringDevice
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 AlignersDevice
Removabale orthodontics appliances
| Study group | Role | What they receive |
|---|---|---|
| Clear Aligners with Dental Monitoring | Experimental | 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. Receives: Device: Clear Aligners with Dental Monitoring |
| Clear Aligners replaced every 7 days | Active comparator | 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. Receives: Device: Clear Aligners |
| Clear Aligners replaced every 14 days | Active comparator | 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. Receives: Device: Clear Aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 to 30 months
Number of refinements plans
Measured: 6 to 30 months
Number of refinement aligners
Measured: 6 to 30 months
The ratio of added trays(refinement)/planned trays.
Measured: 6 to 30 months
Secondary outcomes (3)
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.
Measured: 6 to 30 months
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.
Measured: 6 to 30 months
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)
Measured: 6 to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start17 Oct 2022
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Orthodontists Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573308
- Sponsor's protocol ID
- Protocol # 2021-0644
- Status last verified
- May 2026
- First submitted
- 21 Sep 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 31474272
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Clear Aligners Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms
- ClinicalTrials.gov ID
- NCT05573308
- Acronym / sponsor ID
- Protocol # 2021-0644
- Conditions
- Malocclusion, Misaligned Teeth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- American Association of Orthodontists Foundation
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clear Aligners with Dental Monitoring | Experimental | Device: Clear Aligners with Dental MonitoringExperiment 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. |
| Clear Aligners replaced every 7 days | Active comparator | Device: Clear AlignersGroup 2:Control group. All subjects will have conventional aligner treatment with aligners replaced every 7 days, and standard in-office visits every 8 weeks. |
| Clear Aligners replaced every 14 days | Active comparator | Device: Clear AlignersGroup 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. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear Aligners with Dental MonitoringDental 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 with Dental Monitoring |
| Clear AlignersRemovabale orthodontics appliances | Device | Clear Aligners replaced every 14 days, Clear Aligners replaced every 7 days |
Primary outcome
The number of aligners trays completed with an adequate fit
Time frame: 6 to 30 months
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.
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 31474272Morris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Orthodontics, College of Dentistry University of Illinois Chicago
Chicago, United States
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligners with Dental Monitoring and Clear Aligners in people with Malocclusion and Misaligned Teeth, run by University of Illinois Chicago at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of aligners trays completed with an adequate fit (time frame: 6 to 30 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.