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Gum graft showdown: collagen vs. your own tissue for implants

NCT ID NCT05870774

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested two ways to thicken gum tissue around dental implants: using a collagen matrix or a small piece of the patient's own connective tissue. Fifty-two adults with thin gums received one of the two treatments. The researchers measured gum thickness, pain, swelling, and aesthetics over 6 months to see which method worked better.

What this could mean

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

Active substance
collagen matrix (Fibro-Gide) or connective tissue graft
What this could lead to
If successful, this could show that a collagen matrix is a good alternative to using a patient's own tissue for gum thickening around dental implants.
What could go wrong
This is a small, completed trial with only 52 participants, so results may not apply to everyone. The collagen matrix might not work as well as the natural graft.

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

52 people

The number who actually took part.

Started

Oct 2021

Finished

May 2023

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

25 to 59 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. The presence of written informed consent of the patient to participate in the study; 2. Age from 25 to 59 years; 3. The presence of an included defect in the distal part of the lower jaw with a sufficient volume of bone tissue; 4. Soft tissue thickness \<3 mm on the vestibular side; 5. Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow; 6. Satisfactory level of oral hygiene; 7. Patients without concomitant pathology or with concomitant pathology in the compensation stage. Non-inclusion criteria: 1. Age less than 25 and more than 59 years; 2. Hard smokers (more than 10 cigarettes a day); 3. The presence of concomitant pathology in the stage of decompensation; 4. Patients with malignant tumors, as well as patients with a history of radiation and chemotherapy over the past 5 years; 5. Taking medications that affect the healing of soft tissues (nonsteroidal anti-inflammatory drugs, steroid drugs); 6. Pregnancy and breastfeeding; 7. Patients with mental disorders. Exclusion Criteria: 1. Patients with infections either periodontally or periapically, which developed after inclusion in the study; 2. Pregnancy following entrance into the study; 3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures; 4. Patients who, for one reason or another, could not complete the entire protocol to the end.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • I.M. Sechenov First Moscow State Medical University

    Moscow, 119991, Russia

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