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Can a simple checklist predict how well dental treatment will go for people with down syndrome?

NCT ID NCT05755464

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

Researchers are testing a form that dentists fill out to score how cooperative a person with Down syndrome is likely to be during dental and orthodontic treatment. The form is completed at the first visit and updated later. The goal is to see whether the score helps dentists choose a treatment plan with the lowest risk of failure. The study includes people with Down syndrome who need dental care or have malocclusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A clinician-filled evaluation form to score patient cooperation during dental and orthodontic visits
What this could lead to
If the form works, dentists could choose treatments that match each patient's ability to cooperate, lowering the risk of failed procedures.
What could go wrong
The tool is new and unproven. Cooperation can vary from visit to visit, so a single score may not reliably predict behavior over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Started

Sep 2018

Finished

Dec 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study is expected to evaluate 100 Italian patients aged between 9 and 16 years with DS, who require an evaluation of dental malocclusion and orthodontic correction.

Ages

9 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Down Syndrome * Need of Dental treatment * malocclusion Exclusion Criteria: * other existing pathologies

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Conditions

The condition(s) this trial relates to.

Down syndrome Patient Compliance Stomatognathic Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Down syndrome

More trials for these conditions

Other studies related to the condition(s) this trial covers.