Surgery with a previous non-surgical approach
ProcedureNon-surgical phase done prior to the surgical treatment of peri-implantitis
NCT Number: NCT03620331
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology, Roma, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Non-surgical phase done prior to the surgical treatment of peri-implantitis
Non-surgical phase not done prior to the surgical treatment of peri-implantitis
Time frame: 1 year post-surgery
Time frame: 1 year post-surgery
Measured from the mucosal margin to the bottom of the probeable pocket.
Universidad Complutense de Madrid
Other
Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach: a Multi-center Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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