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Needle vs. needle: botox and filler go Head-to-Head for gummy smile fix

NCT ID NCT07715331

Symptom relief Sponsor: Al-Azhar 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This trial tests two non-surgical injectable treatments for a gummy smile, where too much gum shows when smiling. Twenty adults with a gummy smile of 3 mm or more received either botulinum toxin (Botox) or a hyaluronic acid filler. The study measures how much the gum exposure is reduced and how satisfied patients are with their smile over six months.

What this could mean

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

Active substance
botulinum toxin type A (Refinex) or cross-linked hyaluronic acid filler (Juvéderm Voluma with lidocaine)
What this could lead to
If successful, this could provide a non-surgical, office-based option for people bothered by a gummy smile, improving confidence and quality of life.
What could go wrong
This is a small, early-stage trial with only 20 participants, so results may not apply to everyone. The effects of botulinum toxin may wear off within months, requiring repeat treatments.

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

20 people

The number who actually took part.

Started

Jan 2025

Finished

Feb 2026

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 45 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. Excessive gingival display \>3 mm during maximal smiling (measured by UNC-15 periodontal probe) 2. Age 18-45 years 3. Either sex 4. Ability to provide written informed consent 5. Availability for all follow-up visits at 1, 3, and 6 months post-treatment Exclusion Criteria: 1. Chronic neurological diseases or blood coagulation disorders 2. Pregnancy or lactation 3. Immunological disease or current immunosuppressive drug therapy 4. Known sensitivity or allergy to botulinum toxin or hyaluronic acid products 5. Previous treatment for gummy smile within 12 months 6. Extreme age (outside 18-45 range) or pediatric patients

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Conditions

The condition(s) this trial relates to.

gingival disorder gingival overgrowth

As listed by the trial registrant

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

Esthetics, dental Excessive gingival display Gingival diseases Gummy smile

Contacts and locations

Locations

  • Faculty of Dental Medicine for Girls, Al-Azhar University

    Cairo, Cairo Governorate, Egypt

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