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A plastic stent may replace surgery for gummy smile

NCT ID NCT06983262

Disease control Sponsor: taher helmy ismail metwaly 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial tests whether a custom-made plastic stent (PEEK) can reduce a gummy smile as effectively as standard lip repositioning surgery. Sixteen healthy adults with a gummy smile due to a short, hypermobile upper lip will be randomly assigned to one of the two treatments. Researchers will measure pain, swelling, healing, and how much gum shows when smiling.

What this could mean

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

Active substance
Milled polyether ether ketone (PEEK) stent
What this could lead to
If successful, this could offer a less invasive alternative to surgery for reducing gummy smile.
What could go wrong
This is a small early trial with only 16 participants, so results may not apply to everyone. The stent is a new approach and may not work as well as surgery.

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

16 people

The number who actually took part.

Started

Feb 2024

Finished

Apr 2025

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

20 years and older

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: * Systemically healthy individuals * Chiefs complain gummy smile * Gummy smile due to short hypermobile upper lip * Gingival Display not more than 5 mm Exclusion Criteria: * Pregnancy * Lactation * History of smoking more than 10 cigarettes per day * Systemic conditions or intake of medications that could affect soft and hard tissue healing * Use of orthodontic appliances * Gingival display above 5mm

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As listed by the trial registrant

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

Gummy smile

Contacts and locations

Locations

  • Faculty of Dentistry, Alexandria University

    Alexandria, Egypt

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