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| Name | Class |
|---|---|
| Azienda Policlinico Umberto I | OTHER |
| University of Turin, Italy | OTHER |
| Osteology Foundation | OTHER |
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Randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Surgical + Surgical | Active Comparator | Non surgical approach (NS) followed by surgical treatment (S) of peri-implantitis |
|
| Immediate Surgery | Experimental | Direct surgical approach (S), without a previous non surgical approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery with a previous non-surgical approach | Procedure | Non-surgical phase done prior to the surgical treatment of peri-implantitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Resolution | 1 year post-surgery | |
| Probing Pocket Depth changes | Measured from the mucosal margin to the bottom of the probeable pocket. | 1 year post-surgery |
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Inclusion Criteria:
Any patient having at least one implant affected by severe peri-implantitis, being at least 18 years old and able to sign an informed consent form will be potentially eligible for this trial.
Severe peri-implantitis will be defined as peri-implant probing pocket depth [PPD] ≥6 mm in at least 1 site of the implant, together with bleeding and/or suppuration on probing [BoP and/or SoP, respectively] and radiographically documented marginal bone loss/level ≥3 mm (Carcuac et al. 2016) on implants in function by at least 1 year. In case of absence of baseline radiographs, the reference point for baseline bone levels will be considered where bone was likely to be at implant placement.
Exclusion Criteria:
Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrolment phase.
Systemic primary exclusion criteria:
Local primary exclusion criteria:
Secondary exclusion criteria:
- uncompliant patients (poor oral hygiene 2 weeks after OHI).
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz Alonso | Department of Periodontology, University Complutense Madrid, Spain | Study Chair |
| Luca Cordaro | Department of Periodontology and Prosthodontics, "Umberto I" Policlinic - "G. Eastman" Section | Study Chair |
| Mario Romandini | Department of Periodontology, University Complutense Madrid, Spain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology | Roma | Italy | ||||
| Department of Surgical Sciences, C.I.R. Dental School, University of Turin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36085409 | Derived | Romandini M, Lafori A, Pedrinaci I, Baima G, Ferrarotti F, Lima C, Paterno Holtzman L, Aimetti M, Cordaro L, Sanz M. Effect of sub-marginal instrumentation before surgical treatment of peri-implantitis: A multi-centre randomized clinical trial. J Clin Periodontol. 2022 Dec;49(12):1334-1345. doi: 10.1111/jcpe.13713. Epub 2022 Sep 9. |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery without a previous non-surgical approach | Procedure | Non-surgical phase not done prior to the surgical treatment of peri-implantitis |
|
| Turin |
| Italy |
| Department of Periodontology, University Complutense Madrid, Spain | Madrid | Spain |