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Invisalign offers hope for safer smiles in osteogenesis imperfecta

NCT ID NCT04815564

Symptom relief Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests whether Invisalign clear aligners can safely straighten teeth in people with Osteogenesis Imperfecta (OI), a condition that makes bones brittle and dental work risky. About 57 participants aged 12 to 40 with mild to moderate teeth misalignment will receive treatment at three centers. The goal is to see if clear aligners are effective and less invasive than traditional braces, potentially creating new guidelines for orthodontic care in OI.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 57 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Ages

12 to 40 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: 1. Clinical diagnosis of OI. 2. Malocclusion of intermediate severity defined as a PAR score between 15 and 50. 3. Age range 12 to 40 years at the screening visit. 4. Presence of minimum number of intact teeth to proceed with orthodontic treatment. Exclusion Criteria: 1. Prior orthodontic treatment defined as - any history of braces, palatal expansion or Invisalign treatment. 2. Candidates who meet the PAR score but need surgical intervention for correction of malocclusion 3. Presence of impacted or retained teeth. 4. Use of medication, other than bisphosphonates, known to affect bone metabolism and contraindicated on orthodontic treatment, examples are, growth hormone, corticosteroids (chronic use) and thyroid hormones. 5. Presence of other dental, oral or systemic conditions that may interfere with orthodontic treatment. Examples are severe gingivitis, active periodontal disease, cancer. 6. Pregnancy - positive during screening visit.

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Conditions

The condition(s) this trial relates to.

osteogenesis imperfecta

As listed by the trial registrant

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

Osteogenesis imperfecta

Contacts and locations

Locations

  • McGill University

    Montreal, Quebec, H3A 1G1, Canada

  • Nidcr/Nih

    Bethesda, Maryland, 20892-1470, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

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