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

NCT04323540 | Completed

• 1 other identifier: 18117
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level

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

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

Secondary Outcomes (17)

• Probing depth

  6, 12, 18, 24 months

• Disease resolution

  6, 12, 18, 24 months

• Mucosal recession

  6, 12, 18, 24 months

• plaque index (minimum value 0, maximum 1)

  6, 12, 18, 24 months

• profuse bleeding

  6, 12, 18, 24 months

Study Arms (2)

Xenograft+collagen membrane

ACTIVE COMPARATOR

Reconstructive approach (Xenograft+collegen membrane)

Procedure: Peri-implantitis reconstructive surgery

Xenograft+collagen membrane+autologous soft tissue graft

EXPERIMENTAL

Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)

Procedure: Peri-implantitis reconstructive surgery

Interventions

Peri-implantitis reconstructive surgery PROCEDURE

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.

Xenograft+collagen membrane; Xenograft+collagen membrane+autologous soft tissue graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Eastman Dental Hospital, Italy: lead
• University of Belgrade: collaborator

Study Sites (1)

George Eastman Dental Hospital

Roma, 00100, Italy

Location

Related Publications (1)

• 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.

  PMID: 41618697 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luca Cordaro, MD, PhD

  G. Eastman Dental Hospital Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: February 5, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)