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Gum graft boosts implant infection repair?

NCT ID NCT04323540

Disease control Sponsor: George Eastman Dental Hospital, Italy 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two surgical treatments for peri-implantitis, a serious gum infection around dental implants. Both methods used bone grafting, but one group also received a soft tissue graft from the palate. The trial involved 32 adults and measured gum health, bone loss, and patient satisfaction. Results will help determine if adding the soft tissue graft improves outcomes.

What this could mean

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

Active substance
surgical procedure (bone graft with or without soft tissue graft)
What this could lead to
If successful, this could lead to a more effective surgical approach for treating peri-implantitis, potentially improving implant survival and gum health.
What could go wrong
This is a small, early-stage trial with only 32 participants, so results may not apply to everyone. The added surgery for the soft tissue graft also carries risks like pain, swelling, or graft failure.

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

32 people

The number who actually took part.

Started

Feb 2021

Finished

Jan 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 years and older

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: * · Be able and willing to provide consent and sign the informed consent form. * Be able and willing to comply with study procedures and follow-up appointments required by the study protocol. * Age\>18 years * Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) \>6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of \>3 mm from that level will be considered. * Implants in function (i.e. loaded) for at least 1 year. * Screw- and cement-retained suprastructures for both fixed and removable prostheses. Exclusion Criteria: * Compromised systemic health which contraindicates the study procedures. * Pregnant or nursing women. * Cigarette smoking\>5 per day * Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c\<7% will be enrolled. * Patients taking medications known to interfere with gingival or bone metabolism.

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Conditions

The condition(s) this trial relates to.

Peri-Implantitis

As listed by the trial registrant

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

Peri-implantitis

Contacts and locations

Locations

  • George Eastman Dental Hospital

    Roma, 00100, Italy

More trials for these conditions

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