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

February 9, 2026 updated by: Oasi Research Institute-IRCCS
This study aims to assess patient adherence to orthodontic treatment with dental aligners delivered through remote monitoring compared with in-person care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • EN
      • Troina, EN, Italy, 94018
        • Oasi Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote monitoring aligner
Device: Remotely monitored orthodontic aligner treatment
Remotely monitored orthodontic aligner treatment
Active Comparator: In-person care monitoring aligner
Device: In-person monitored orthodontic aligner treatment
In-person monitored orthodontic aligner treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: From enrollment through the monitoring phase of approximately 4 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oasi Research Institute-IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • RC-2794677 (aligners)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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