search
Back to results

Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms

Primary Purpose

Malocclusion, Misaligned Teeth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clear Aligners with Dental Monitoring
Clear Aligners
Sponsored by
Mohammed H Elnagar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Orthodontic Specialists of Lake County (Antioch)Recruiting
  • Department of Orthodontics, College of Dentistry University of Illinois ChicagoRecruiting
  • Orthodontic Specialists of Lake County (Grayslake)Recruiting
  • Orthodontic Specialists of Lake County (Gurnee)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Clear Aligners with Dental Monitoring

Clear Aligners replaced every 7 days

Clear Aligners replaced every 14 days

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Number of refinements plans
Number of refinement aligners
The ratio of added trays(refinement)/planned trays.

Secondary Outcome Measures

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.
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.
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)

Full Information

First Posted
September 21, 2022
Last Updated
October 6, 2022
Sponsor
Mohammed H Elnagar
search

1. Study Identification

Unique Protocol Identification Number
NCT05573308
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohammed H Elnagar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Misaligned Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clear Aligners with Dental Monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Clear Aligners replaced every 7 days
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Clear Aligners replaced every 14 days
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Clear Aligners with Dental Monitoring
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Clear Aligners
Intervention Description
Removabale orthodontics appliances
Primary Outcome Measure Information:
Title
The number of aligners trays completed with an adequate fit
Description
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.
Time Frame
6 to 30 months
Title
Number of refinements plans
Time Frame
6 to 30 months
Title
Number of refinement aligners
Time Frame
6 to 30 months
Title
The ratio of added trays(refinement)/planned trays.
Time Frame
6 to 30 months
Secondary Outcome Measure Information:
Title
ABO Discrepancy Index
Description
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.
Time Frame
6 to 30 months
Title
The American Board of Orthodontics (ABO) Objective grading system (OGS)
Description
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.
Time Frame
6 to 30 months
Title
Degree of tooth movement
Description
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)
Time Frame
6 to 30 months
Other Pre-specified Outcome Measures:
Title
Number of office visits
Description
Number of office visits needed to finish the treatment
Time Frame
6 to 30 months
Title
Patient compliance
Time Frame
6 to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Orthodontic Specialists of Lake County (Antioch)
City
Antioch
State/Province
Illinois
ZIP/Postal Code
60002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannin Greco
Phone
847-838-0105
Email
shannin@osolc.com
Facility Name
Department of Orthodontics, College of Dentistry University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Elnagar, DDS, MS.PhD
Phone
312-996-7505
Email
melnagar@uic.edu
First Name & Middle Initial & Last Name & Degree
Lia Tahir, DDS
Phone
312-996-7505
Email
atahir3@uic.edu
Facility Name
Orthodontic Specialists of Lake County (Grayslake)
City
Grayslake
State/Province
Illinois
ZIP/Postal Code
60030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannin Greco
Phone
847-223-2876
Email
shannin@osolc.com
Facility Name
Orthodontic Specialists of Lake County (Gurnee)
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannin Greco
Phone
847-249-1000
Email
shannin@osolc.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31474272
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.
Results Reference
background

Learn more about this trial

Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms

We'll reach out to this number within 24 hrs