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Gum gel injection offers hope for black triangle smile fix

NCT ID NCT07185191

Symptom relief Sponsor: Mastelli S.r.l 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a gel made from natural particles (polynucleotides) injected into the gums to treat black triangles—gaps between teeth caused by gum loss. About 40 adults with at least one black triangle in the smile zone will receive the gel. The goal is to see if it safely fills the gap and improves gum appearance without 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

About 40 people

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

Started

Apr 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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: 1. Be able to provide written informed consent (ICF) for the study. 2. Males and females. 3. Be aged 18 years or older at the time of signing the informed consent. 4. Subjects have to show at least one anterior interdental papilla recession in the smile zone according to Jemt's classification (BTS). 5. The teeth near the interdental papilla recession must have the contact point. 6. Absence of periodontal diseases. 7. Subjects with adequate knowledge of domiciliary oral hygiene practices, as measured by the following parameters: FMPS (full mouth plaque score) and FMBS (full mouth bleeding score) values \<10%. 8. Absence of plaque and bleeding on probing at the site of interest. 9. Absence of retentive factors at the site of interest. Exclusion Criteria: 1. Subjects with active periodontitis. 2. Presence of an acute infection in the oral cavity or upper respiratory tract. 3. Pregnancy or breastfeeding or planning to conceive from the clinical evaluation for enrollment up to 120 days after the end of the treatment. 4. Subjects must not be Smokers more than 10 cigarettes per day. 5. Presence of bleeding disorders or taking medications that affect blood clotting (e.g., coumarin-type drugs or platelet aggregation inhibitors). 6. Presence of systemic diseases that could affect periodontal health. 7. Patients with autoimmune diseases. 8. Known or suspected allergy to seafood products. 9. Psychiatric or behavioral disorders or substance abuse that would interfere with the necessary cooperation for the study. 10. Presence of infra-bony defects associated with pocket or papilla contraction and visible on X-ray as well as detectable on probing.

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Conditions

The condition(s) this trial relates to.

gingival recession

As listed by the trial registrant

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

Black triangles syndrome (BTS) Periodontal gingival contraction

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

  • Azienda Socio Sanitaria Territoriale (A.S.S.T.) degli Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy, 25123, Italy

More trials for these conditions

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