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Which frenum surgery works best? small trial aims to settle the debate

NCT ID NCT06331325

Disease control Sponsor: October University for Modern Sciences and Arts 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed trial compared two surgical techniques—frenotomy and frenectomy—for treating high frenum attachment in 46 healthy, non-smoking adults. The goal was to see which procedure leads to less relapse and less pain. Participants were randomly assigned to one of the two surgeries, and their frenum level was measured before and six months after, with pain scores recorded during the first week.

What this could mean

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

Active substance
Frenotomy and frenectomy surgical procedures
What this could lead to
If successful, this could help dentists choose the better technique for reducing relapse and pain in adults with high frenum attachment.
What could go wrong
This is a small, completed trial with only 46 participants, so results may not apply to everyone. The procedures are surgical and carry typical risks like pain and infection.

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

46 people

The number who actually took part.

Started

Mar 2024

Finished

Dec 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

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: * Adults with active highly attached maxillary/mandibular labial frenum. * Systemically healthy * Non-smokers * Gingival and plaque index \<10% Exclusion Criteria: * Poor oral hygiene. * Smokers * Any systemic diseases or medications that delay wound healing. * Pregnant or lactating females * Previous frenal procedures.

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Conditions

The condition(s) this trial relates to.

ankyloglossia

As listed by the trial registrant

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

High frenum attachment

Contacts and locations

Locations

  • MSA University

    Giza, 12566, Egypt