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Peri-ImplantitisNCT04323540

Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation

A study testing Peri-implantitis reconstructive surgery in people with Peri-Implantitis, run by George Eastman Dental Hospital, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peri-Implantitis
What is being tested?
Peri-implantitis reconstructive surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteItaly
Study dates
5 Feb 2021to 1 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • · 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • George Eastman Dental Hospital

    Roma, 00100

Other trials in Italy

About this study

Official title: Surgical Reconstructive Treatment of Peri-Implantitis With or Without Simultaneous Soft Tissue Augmentation: a Multi-center Randomized Controlled Trial

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials.

Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, surgical characteristics, and patient-reported outcome measures, including an aesthetic self-evaluation.

Read the detailed description

The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects.

More specifically, the control group will be a "pure" reconstructive approach (xenograft bone graft granules and resorbable collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). This is in accordance with gold standard practices of reconstructive therapy of peri-implant defects.

The test group will be treated with the same approach and materials, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to the grafting materials. The graft will be harvested from the homolateral palate (molar region).

Outcomes will include clinical attachment level (CAL; primary outcome), probing depth (PD), mucosal recession (MR), defect resolution (a composite outcome defined as the simultaneous absence of PD > 5 mm, bleeding on probing [BOP] and/or suppuration [SUP], and bone level changes > 0.5 mm), plaque index (PI), BOP, suppuration on probing, suppuration on palpation, surgical duration, the Early Wound Healing Index (EHI), and patient-reported outcome measures (PROMs), including aesthetic self-evaluation.

PROMs will assess patients' perception of surgery, pain intensity, perceived swelling, perceived bleeding, and analgesic intake.

Clinical measurements will be recorded at baseline and at 6, 12, 18, and 24 months. EHI will be assessed at 1 and 2 weeks postoperatively. Radiographic bone levels at 12 and 24 months will be compared with those recorded on radiographs obtained at baseline. All PROMs variables, as well as aesthetic self-evaluation, will be collected using specially designed questionnaires completed by the patients. PROMs data will be recorded at 4, 8, and 12 hours after surgery on the day of surgery (day 0), and daily from postoperative day 2 to day 7. Aesthetic self-evaluation will be recorded at baseline and at 6, 12, and 24 months postoperatively.

Being tested
Peri-implantitis reconstructive surgery
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peri-implantitis reconstructive surgeryProcedure or surgery

    For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture.

    Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area.

    Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap.

Study groups in NCT04323540
Study groupRoleWhat they receive
Xenograft+collagen membraneActive comparatorReconstructive approach (Xenograft+collegen membrane)
Receives: Procedure: Peri-implantitis reconstructive surgery
Xenograft+collagen membrane+autologous soft tissue graftExperimentalReconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)
Receives: Procedure: Peri-implantitis reconstructive surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical attachment level

    linear distance (mm) from the implant platform to the bottom of the pocket

    Measured: change from baseline to: 6, 12, 18, 24 months

Secondary outcomes (17)

  1. Probing depth

    linear distance (mm) from the gingival margin to the bottom of the pocket

    Measured: 6, 12, 18, 24 months

  2. Disease resolution

    No PD greater than or equal to 5 mm and simultaneous absence of BOP/SUP and no more than 0.5 mm change between 2 weeks and 12 and 24 months on radiograph

    Measured: 6, 12, 18, 24 months

  3. Mucosal recession

    linear distance (mm) from the implant platform to the gingival margin

    Measured: 6, 12, 18, 24 months

  4. plaque index (minimum value 0, maximum 1)

    binary outcome: yes/ no detected running the probe into the peri-implant sulcus

    Measured: 6, 12, 18, 24 months

  5. profuse bleeding

    abundant bleeding evoked upon probing immediately after

    Measured: 6, 12, 18, 24 months

  6. BOP

    bleeding upon probing: bleeding evoked upon probing after 1 second

    Measured: 6, 12, 18, 24 months

  7. suppuration

    Binary: yes or no, detected upon probing or digital palpation

    Measured: 6, 12, 18, 24 months

  8. Gingival thickness

    Measured in a horizontal direction at 1 mm from the gingival margin

    Measured: 6, 12, 18, 24 months

  9. PROMs - Patient perception of surgery

    Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate a more positive perception of the surgical procedure.

    Measured: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery

  10. Radiographic bone levels

    radiographic bone level changes between the 2 week and 12 and 24 month follow-ups

    Measured: 2 weeks, 12 months, 24 months

  11. PROMs - Patient-reported pain intensity

    Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater pain intensity.

    Measured: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery

  12. PROMs - Patient-reported swelling

    Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived swelling.

    Measured: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery

  13. PROMs - Patient-reported bleeding

    Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived bleeding.

    Measured: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery

  14. PROMs - Analgesic consumption

    Number of analgesic tablets consumed by the patient during the first postoperative week.

    Measured: 12 hours after surgery and daily from day 2 through day 7 after surgery

  15. PROMs - aesthetic self-evaluation

    Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater satisfaction with the esthetic outcome.

    Measured: Baseline, 6 months, 12 months, and 24 months

  16. Early wound healing

    Wound healing scores ranging from 1 to 5 by the surgeon

    Measured: 1 week and 2 weeks after surgery

  17. Surgical duration

    The interval between the initial incision and placement of the final suture, measured in minutes.

    Measured: at the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start5 Feb 2021
  3. Primary completion1 Jan 2025
  4. Study completion1 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04323540
Sponsor's protocol ID
18117
Status last verified
Jun 2026
First submitted
23 Mar 2020
Last updated
24 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Holtzman LP, Milinkovic I, Vuckovic M, Malpassi C, Cuppini M, Solderer A, Aleksic Z, Cordaro L. Effect of Connective Tissue Graft as an Adjunct to Guided Bone Regeneration in the Surgical Treatment of Peri-Implantitis: A Dual-Center Randomized Controlled Trial. Clin Oral Implants Res. 2026 Apr;37(4):478-495. doi: 10.1111/clr.70093. Epub 2026 Jan 31.

    PubMed 41618697

Questions about this trial

What is this clinical trial studying?

A study testing Peri-implantitis reconstructive surgery in people with Peri-Implantitis, run by George Eastman Dental Hospital, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical attachment level (time frame: change from baseline to: 6, 12, 18, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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