NCT07413003

Brief Summary

This study aims to assess patient adherence to orthodontic treatment with dental aligners delivered through remote monitoring compared with in-person care.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress91%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

January 30, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 30, 2026

Last Update Submit

February 9, 2026

Conditions

Mild Intellectual Disability

Outcome Measures

Primary Outcomes (1)

  • Treatment adherence

    The assessment and quantification will be carried out using a dedicated record. A clinical evaluation will also be performed.

    From enrollment through the monitoring phase of approximately 4 months.

Study Arms (2)

Remote monitoring aligner

EXPERIMENTAL
Device: Remotely monitored orthodontic aligner treatment

In-person care monitoring aligner

ACTIVE COMPARATOR
Device: In-person monitored orthodontic aligner treatment

Interventions

Remotely monitored orthodontic aligner treatmentDEVICE

Remotely monitored orthodontic aligner treatment

Remote monitoring aligner
In-person monitored orthodontic aligner treatmentDEVICE

In-person monitored orthodontic aligner treatment

In-person care monitoring aligner

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 11 and 12 years
  • Diagnosis of mild intellectual disability
  • Presence of dental malocclusion requiring orthodontic treatment with aligner

You may not qualify if:

  • \- Presence of dental malocclusion requiring orthodontic treatment with a fixed appliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oasi Research Institute

Troina, EN, 94018, Italy

Location

Related Publications (1)

  • Ferlito T, Hsiou D, Hargett K, Herzog C, Bachour P, Katebi N, Tokede O, Larson B, Masoud MI. Assessment of artificial intelligence-based remote monitoring of clear aligner therapy: A prospective study. Am J Orthod Dentofacial Orthop. 2023 Aug;164(2):194-200. doi: 10.1016/j.ajodo.2022.11.020. Epub 2023 Mar 28.

    PMID: 36997411RESULT

Central Study Contacts

Antonio Fallea

CONTACT

+39 3381113255afallea@oasi.en.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 17, 2026

Study Start

March 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-01

Locations

IT(1)