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

19. Juni 2026 aktualisiert von: Lucrezia Paternò Holtzman, George Eastman Dental Hospital, Italy

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

32

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Italien
      • Roma, Italien, 00100
        • George Eastman Dental Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Xenograft+collagen membrane
Reconstructive approach (Xenograft+collegen membrane)
Verfahren: Peri-implantitis reconstructive 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.
Experimental: Xenograft+collagen membrane+autologous soft tissue graft
Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)
Verfahren: Peri-implantitis reconstructive 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical attachment level
Zeitfenster: change from baseline to: 6, 12, 18, 24 months
linear distance (mm) from the implant platform to the bottom of the pocket
change from baseline to: 6, 12, 18, 24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Probing depth
Zeitfenster: 6, 12, 18, 24 months
linear distance (mm) from the gingival margin to the bottom of the pocket
6, 12, 18, 24 months
Disease resolution
Zeitfenster: 6, 12, 18, 24 months
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
6, 12, 18, 24 months
Mucosal recession
Zeitfenster: 6, 12, 18, 24 months
linear distance (mm) from the implant platform to the gingival margin
6, 12, 18, 24 months
plaque index (minimum value 0, maximum 1)
Zeitfenster: 6, 12, 18, 24 months
binary outcome: yes/ no detected running the probe into the peri-implant sulcus
6, 12, 18, 24 months
profuse bleeding
Zeitfenster: 6, 12, 18, 24 months
abundant bleeding evoked upon probing immediately after
6, 12, 18, 24 months
BOP
Zeitfenster: 6, 12, 18, 24 months
bleeding upon probing: bleeding evoked upon probing after 1 second
6, 12, 18, 24 months
suppuration
Zeitfenster: 6, 12, 18, 24 months
Binary: yes or no, detected upon probing or digital palpation
6, 12, 18, 24 months
Gingival thickness
Zeitfenster: 6, 12, 18, 24 months
Measured in a horizontal direction at 1 mm from the gingival margin
6, 12, 18, 24 months
Radiographic bone levels
Zeitfenster: 2 weeks, 12 months, 24 months
radiographic bone level changes between the 2 week and 12 and 24 month follow-ups
2 weeks, 12 months, 24 months
PROMs - Patient perception of surgery
Zeitfenster: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate a more positive perception of the surgical procedure.
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
PROMs - Patient-reported pain intensity
Zeitfenster: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater pain intensity.
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
PROMs - Patient-reported swelling
Zeitfenster: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived swelling.
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
PROMs - Patient-reported bleeding
Zeitfenster: 4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater perceived bleeding.
4 hours, 8 hours, 12 hours, and Days 2-7 after surgery
PROMs - Analgesic consumption
Zeitfenster: 12 hours after surgery and daily from day 2 through day 7 after surgery
Number of analgesic tablets consumed by the patient during the first postoperative week.
12 hours after surgery and daily from day 2 through day 7 after surgery
PROMs - aesthetic self-evaluation
Zeitfenster: Baseline, 6 months, 12 months, and 24 months
Assessed using a 100-mm visual analog scale (VAS), where higher scores indicate greater satisfaction with the esthetic outcome.
Baseline, 6 months, 12 months, and 24 months
Early wound healing
Zeitfenster: 1 week and 2 weeks after surgery
Wound healing scores ranging from 1 to 5 by the surgeon
1 week and 2 weeks after surgery
Surgical duration
Zeitfenster: at the surgery
The interval between the initial incision and placement of the final suture, measured in minutes.
at the surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

George Eastman Dental Hospital, Italy

Mitarbeiter

University of Belgrade

Ermittler

  • Hauptermittler: Luca Cordaro, MD, PhD, G. Eastman Dental Hospital Rome, Italy

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Februar 2021

Primärer Abschluss (Tatsächlich)

1. Januar 2025

Studienabschluss (Tatsächlich)

1. Januar 2025

Studienanmeldedaten

Zuerst eingereicht

23. März 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. März 2020

Zuerst gepostet (Tatsächlich)

26. März 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 18117 (City of Hope Medical Center)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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