Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation
Surgical Reconstructive Treatment of Peri-Implantitis With or Without Simultaneous Soft Tissue Augmentation: a Multi-center Randomized Controlled Trial
1 other identifier
interventional
32
0 countries
N/A
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, patient-reported outcome measures including an aesthetic self-evaluation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 26, 2020
March 1, 2020
1 year
March 23, 2020
March 25, 2020
Conditions
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 (10)
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
- +5 more secondary outcomes
Study Arms (2)
Xenograft+collagen membrane
ACTIVE COMPARATORReconstructive approach (Xenograft+collegen membrane)
Xenograft+collagen membrane+autologous soft tissue graft
EXPERIMENTALReconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- George Eastman Dental Hospital, Italylead
- University of Belgradecollaborator
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 Jan 31. doi: 10.1111/clr.70093. Online ahead of print.
PMID: 41618697DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Cordaro, MD, PhD
G. Eastman Dental Hospital Rome, Italy
Central Study Contacts
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
September 1, 2020
Primary Completion
September 1, 2021
Study Completion
December 1, 2023
Last Updated
March 26, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share