Etiology of Early Apical Peri-implantitis

Study Overview
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Brief Summary
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A case-control study was performed was performed following the STROBE statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. Data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical peri-implantitis, to determine the frequency and etiology of this pathology.

Detailed Description
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A case-control study was performed following the STROBE statement (17) at the Oral Surgery Department, Faculty of Medicine and Dentistry (University of Valencia, Spain) from 1996 to 2016, in which patients with early peri-implantitis diagnosed were included (Figure 1). All patients were informed about the study design and procedures. Prior to participating, they were requested to sign an informed consent document. The study design was approved by the Ethical Committee of the University of Valencia (H1478255958653). Two groups were established: Test group (patients diagnosed with early apical peri-implantitis diagnosed) and Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated).

Official Title
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Etiology of Early Apical Peri-implantitis: A Case-control Study Over a 20-year Period.

Conditions
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Early Apical Peri-implantitis

Intervention / Treatment
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* Other: Observational intervention to diagnose an early apical peri-implantitis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The following inclusion criteria were applied: patients ≥18 years old and controlled medical conditions who received treatment with implants. Additionally, for the test group, inclusion criteria were: symptoms and signs suggesting early apical peri-implantitis after implant placement; absence of implant mobility; dull percussion of nonsurmerged implants; presence or absence of radiolucency apically. Exclusion Criteria: for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test group<br>Test group (patients diagnosed with early apical peri-implantitis diagnosed) | Other: Observational intervention to diagnose an early apical peri-implantitis<br>* diagnose an early apical peri-implantitis<br>|
| Control group<br>Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated) | Other: Observational intervention to diagnose an early apical peri-implantitis<br>* diagnose an early apical peri-implantitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of surgery | immediate/delayed placement | Intraoperative | 
| tooth-implant distance | mesial and distal tooth-implant distance measured at the apex | Intraoperative | 
| Tooth status | apical lesion or endodontic treatment in the tooth being replaced or adjacent tooth endodontically treated | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early apical peri-implantitis; implant periapical lesion; retrograde peri-implantitis; implant failure