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Not yet recruiting NCT07413003

Comparison of Orthodontic Aligner Treatment Protocols Managed Through Remote Monitoring Versus In-Person Care

No phase Interventional Mild Intellectual Disability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remotely monitored orthodontic aligner treatment, In-person monitored orthodontic aligner treatment.
Who it may be relevant to
Registry conditions: Mild Intellectual Disability. Basic parameters: 11 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Device Remotely monitored orthodontic aligner treatment
    Remotely monitored orthodontic aligner treatment
  • Device In-person monitored orthodontic aligner treatment
    In-person monitored orthodontic aligner treatment

Primary outcome measures

  • Treatment adherence [Time frame: From enrollment through the monitoring phase of approximately 4 months.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Oasi Research Institute — Troina

Publications

  • 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 36997411

Identifiers

NCT: NCT07413003 · RC-2794677 (aligners)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗