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Could a botox Pre-Treatment make gummy smile surgery last longer?

NCT ID NCT06148961

Disease control Sponsor: Cairo University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study investigates whether injecting Botox a few days before modified lip repositioning surgery helps prevent the return of a gummy smile (excessive gum display when smiling) within one year. Twenty adults with a gummy smile and hyperactive upper lip will be enrolled. The trial compares the combination of Botox followed by surgery versus surgery alone, measuring gum display and patient satisfaction.

What this could mean

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

Active substance
botox injection prior to modified lip repositioning surgery
What this could lead to
If successful, this approach could reduce the chance that a gummy smile returns after lip repositioning surgery, offering a more lasting cosmetic solution.
What could go wrong
This is a very small, early-stage trial with only 20 participants, so results may not apply to everyone. Botox is temporary and carries risks like bruising or asymmetry.

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 20 people

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

Started

Feb 2024

Expected to finish

Oct 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

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 that is not satisfied with his smile having excessive gingival display * Adult Age ≥ 21 years. * Systemically and periodontally Healthy patients. * had gingival exposure greater than 3 mm when smiling * had a hyperactive upper lip with or without other causes of EGD (lip displacement ≥ 9 mm) before botox \& ≥ 3mm after. * Cooperative patients able and accept to come for follow up appointments. Exclusion Criteria: * • smoking * pregnancy or lactation * Systemic diseases; neuromuscular,neurological, or psychological disorders or consumption of controlled medication * Patients having medical condition or any drugs that could affect healing * Patients with systemic condition that can't undergo minor oral surgery * Patient allergic to Botox or multiple allergic conditions * have history of previous Botox injection * periodontal disease * excessive gingival display at rest * those who declined the informed consent or who did not consent to the risks described. * Those who have deviate smile

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Conditions

The condition(s) this trial relates to.

gingival overgrowth

As listed by the trial registrant

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

Excessive gingival display

Contacts and locations

Locations

  • Cherine Emad Mahmoud Mohamed Hamada

    Giza, 12566, Egypt

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