NCT05573308

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2022Dec 2027

First Submitted

Initial submission to the registry

September 21, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Expected
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3.2 years

First QC Date

September 21, 2022

Last Update Submit

October 10, 2024

Conditions

MalocclusionMisaligned Teeth

Outcome Measures

Primary Outcomes (4)

  • 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

  • Number of refinements plans

    6 to 30 months

  • Number of refinement aligners

    6 to 30 months

  • The ratio of added trays(refinement)/planned trays.

    6 to 30 months

Secondary Outcomes (3)

  • ABO Discrepancy Index

    6 to 30 months

  • The American Board of Orthodontics (ABO) Objective grading system (OGS)

    6 to 30 months

  • Degree of tooth movement

    6 to 30 months

Other Outcomes (2)

  • Number of office visits

    6 to 30 months

  • Patient compliance

    6 to 30 months

Study Arms (3)

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.

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.

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.

Device: Clear Aligners

Interventions

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 Aligners with Dental Monitoring
Clear AlignersDEVICE

Removabale orthodontics appliances

Clear Aligners replaced every 14 daysClear Aligners replaced every 7 days

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orthodontic Specialists of Lake County (Antioch)

Antioch, Illinois, 60002, United States

RECRUITING

Department of Orthodontics, College of Dentistry University of Illinois Chicago

Chicago, Illinois, 60612-7211, United States

RECRUITING

Orthodontic Specialists of Lake County (Grayslake)

Grayslake, Illinois, 60030, United States

RECRUITING

Orthodontic Specialists of Lake County (Gurnee)

Gurnee, Illinois, 60031, United States

RECRUITING

Related 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.

    PMID: 31474272BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

October 10, 2022

Study Start

October 17, 2022

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2027

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)