Mild Intellectual DisabilityNCT07413003
Comparison of Orthodontic Aligner Treatment Protocols Managed Through Remote Monitoring Versus In-Person Care
A study testing Remotely monitored orthodontic aligner treatment and In-person monitored orthodontic aligner treatment in people with Mild Intellectual Disability, run by Oasi Research Institute-IRCCS at 1 site in Italy.
Trial summary
This study aims to assess patient adherence to orthodontic treatment with dental aligners delivered through remote monitoring compared with in-person care. Read more about this study
- Who is it for?
- Ages 11 to 12 years
- Conditions the study is for
- Mild Intellectual Disability
- What is being tested?
- Remotely monitored orthodontic aligner treatment and In-person monitored orthodontic aligner treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 11 and 12 years
- Diagnosis of mild intellectual disability
- Presence of dental malocclusion requiring orthodontic treatment with aligner
Who cannot join
- Presence of dental malocclusion requiring orthodontic treatment with a fixed appliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Oasi Research Institute
Troina, EN, 94018
Antonio Fallea, +39 3381113255, afallea@oasi.en.it
About this study
This study aims to assess patient adherence to orthodontic treatment with dental aligners delivered through remote monitoring compared with in-person care.
- Conditions
- Mild Intellectual Disability
- Being tested
- Remotely monitored orthodontic aligner treatment, In-person monitored orthodontic aligner treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely monitored orthodontic aligner treatmentDevice
Remotely monitored orthodontic aligner treatment
In-person monitored orthodontic aligner treatmentDevice
In-person monitored orthodontic aligner treatment
| Study group | Role | What they receive |
|---|---|---|
| Remote monitoring aligner | Experimental | Not described Receives: Device: Remotely monitored orthodontic aligner treatment |
| In-person care monitoring aligner | Active comparator | Not described Receives: Device: In-person monitored orthodontic aligner treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence
The assessment and quantification will be carried out using a dedicated record. A clinical evaluation will also be performed.
Measured: From enrollment through the monitoring phase of approximately 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oasi Research Institute-IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413003
- Sponsor's protocol ID
- RC-2794677 (aligners)
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36997411
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Orthodontic Aligner Treatment Protocols Managed Through Remote Monitoring Versus In-Person Care
- ClinicalTrials.gov ID
- NCT07413003
- Acronym / sponsor ID
- RC-2794677 (aligners)
- Conditions
- Mild Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oasi Research Institute-IRCCSUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess patient adherence to orthodontic treatment with dental aligners delivered through remote monitoring compared with in-person care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote monitoring aligner | Experimental | Device: Remotely monitored orthodontic aligner treatment |
| In-person care monitoring aligner | Active comparator | Device: In-person monitored orthodontic aligner treatment |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 11 and 12 years
- Diagnosis of mild intellectual disability
- Presence of dental malocclusion requiring orthodontic treatment with aligner
Key exclusion criteria (1 listed)
- Presence of dental malocclusion requiring orthodontic treatment with a fixed appliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remotely monitored orthodontic aligner treatmentRemotely monitored orthodontic aligner treatment | Device | Remote monitoring aligner |
| In-person monitored orthodontic aligner treatmentIn-person monitored orthodontic aligner treatment | Device | In-person care monitoring aligner |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publication: PubMed 36997411Ferlito 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely monitored orthodontic aligner treatment and In-person monitored orthodontic aligner treatment in people with Mild Intellectual Disability, run by Oasi Research Institute-IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Fallea (+39 3381113255, afallea@oasi.en.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence (time frame: From enrollment through the monitoring phase of approximately 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.