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New study tests gum surgery to speed up braces and improve results

NCT ID NCT06315348

Disease control Sponsor: Universidad Complutense de Madrid Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two flapless surgical techniques used alongside braces to see which better improves gum and bone changes. Forty adults with mild to moderate crowding will receive either a soft tissue graft or a bone graft during their orthodontic treatment. Researchers will measure gum contour, tooth movement speed, and patient comfort over time.

What this could mean

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

Active substance
flapless alveolar decortication with augmentation (piezocision-assisted orthodontics with soft tissue or bone grafting)
What this could lead to
If successful, this could lead to faster, more stable orthodontic results with improved gum and bone health.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The procedures involve surgery and grafting, which carry risks like infection or gum recession.

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 40 people

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

Started

Apr 2024

Expected to finish

Dec 2026

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

16 to 70 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: Patients will be consecutively selected among those attending the Faculty of Odontology, University Complutense (Madrid, Spain) looking for orthodontic therapy. The inclusion criteria will be as follows: * patients requiring maxillary and/or mandible orthodontic treatment; * patients with permanent dentition in stage 5 or 6 of the cervical vertebral maturation method as described by Baccetti et al. (2002); * minimal to moderate maxillary and/or mandibular anterior crowding at baseline (arch length discrepancy from 3-8 mm); and * adequate oral health (i.e. periodontal health, absence of periapical infections and untreated caries). Exclusion Criteria: * subjects with periodontitis stage III or IV (Papapanou et al., 2018); * subjects with poor oral hygiene (represented as full-mouth plaque scores (FMPS) \>25%); * ongoing chronic drug therapy influencing bone metabolism (e.g. steroids, immunosuppressors or antiresorptive drugs); * subjects with uncontrolled systemic diseases (e.g. diabetes); * pregnancy and * subjects not willing to comply with the study visits

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Conditions

The condition(s) this trial relates to.

Binder syndrome Malocclusion Retrognathia

As listed by the trial registrant

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

Dental malocclusion Maxillary deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of Odontology, University Complutense Madrid

    RECRUITING

    Madrid, 28040, Spain

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