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New collagen graft aims to boost gum health around same-day dental implants

NCT ID NCT05081284

Disease control Sponsor: University of Pisa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a volume-stable collagen graft around dental implants placed right after tooth extraction improves gum thickness compared to no graft. Forty patients with a single failing tooth in the front region are enrolled. The main outcome is soft tissue thickness measured at 3 and 6 months after surgery.

What this could mean

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

Active substance
Volume-stable collagen matrix (Geistlich Fibro-Gide)
What this could lead to
If it works, this could improve gum thickness and appearance around dental implants, leading to better long-term dental health.
What could go wrong
This is a small, early-stage trial with only 40 participants. The collagen graft may not provide significant benefit over standard care, and results may not apply to all patients.

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

Jan 2022

Expected to finish

Dec 2027

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 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: \- Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies. Exclusion Criteria: * Patients who are heavy smokers (more than 10 cigarettes/day); * Patients who suffer from any systemic diseases that could negatively influence wound healing; * Patients who received head and neck radiation treatment; * Patients who have a full contraindication to implant surgery; * Patients who have uncontrolled periodontal disease; * Patients who show a full mouth plaque and bleeding score higher than 25%; * Patients who have deficient extraction sockets according to the classification of Juodzbalys et al. 2008. * Patients with known allergy, sensitivity or intolerance to collagen * Patients who are pregnant or who are breastfeeding

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As listed by the trial registrant

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

Edentulous alveolar ridge

Contacts and locations

Locations

  • U.O. Odontostomatologia e Chirurgia del Cavo Orale

    Pisa, Italy, 56126, Italy

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