Clinical trial NCT03523845: Etiology of Early Apical Peri-implantitis
Official title: Etiology of Early Apical Peri-implantitis: A Case-control Study Over a 20-year Period.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Apical Peri-implantitis
Keywords: "early apical peri-implantitis"; "implant periapical lesion"; "retrograde peri-implantitis"; "implant failure"
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients who received at least one dental implant

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: type of surgery
timeFrame: Intraoperative
measure: tooth-implant distance
timeFrame: Intraoperative
measure: Tooth status
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor and Chairman of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, Spain
name: Miguel Peñarrocha Diago, MD, MDM, PhD
role: STUDY_CHAIR
affiliation: Master of Oral Surgery and Implantology
name: Juan Antonio Blaya Tárraga, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quirynen M, Gijbels F, Jacobs R. An infected jawbone site compromising successful osseointegration. Periodontol 2000. 2003;33:129-44. doi: 10.1046/j.0906-6713.2002.03311.x. No abstract available.
citation: Lefever D, Van Assche N, Temmerman A, Teughels W, Quirynen M. Aetiology, microbiology and therapy of periapical lesions around oral implants: a retrospective analysis. J Clin Periodontol. 2013 Mar;40(3):296-302. doi: 10.1111/jcpe.12045. Epub 2012 Dec 27.
citation: Penarrocha-Diago M, Maestre-Ferrin L, Cervera-Ballester J, Penarrocha-Oltra D. Implant periapical lesion: diagnosis and treatment. Med Oral Patol Oral Cir Bucal. 2012 Nov 1;17(6):e1023-7. doi: 10.4317/medoral.17996.
citation: Zhao D, Wu Y, Xu C, Zhang F. Immediate dental implant placement into infected vs. non-infected sockets: a meta-analysis. Clin Oral Implants Res. 2016 Oct;27(10):1290-1296. doi: 10.1111/clr.12739. Epub 2015 Dec 15.