An interventional study of Surgery with a previous non-surgical approach and Surgery without a previous non-surgical approach in Peri-Implantitis, sponsored by Universidad Complutense de Madrid. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.
This study's enrollment of 42 is close to the median of 40 across 182 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 approach (NS) followed by surgical treatment (S) of peri-implantitis
Procedure: Surgery with a previous non-surgical approach
Direct surgical approach (S), without a previous non surgical approach
Procedure: Surgery without a previous non-surgical approach
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
Disease Resolution
Time frame: 1 year post-surgery
Probing Pocket Depth changes
Measured from the mucosal margin to the bottom of the probeable pocket.
Time frame: 1 year post-surgery
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Universidad Complutense de Madrid