Etiology of Early Apical Peri-implantitis (EAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Early Apical Peri-implantitis
• Intervention / Treatment: Other: Observational intervention to diagnose an early apical peri-implantitis

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).

• Study Type: Observational
• Enrollment (Actual): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients who received at least one dental implant

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test group; Test group (patients diagnosed with early apical peri-implantitis diagnosed)	Other: Observational intervention to diagnose an early apical peri-implantitis; diagnose an early apical peri-implantitis
Control group; 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; diagnose an early apical peri-implantitis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Study Chair: Miguel Peñarrocha Diago, MD, MDM, PhD, Professor and Chairman of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, Spain; Principal Investigator: Juan Antonio Blaya Tárraga, DDS, MSc, Master of Oral Surgery and Implantology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1996
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: "early apical peri-implantitis"; "implant periapical lesion"; "retrograde peri-implantitis"; "implant failure"
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: LPI1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: higher permissions are needed to make the decision

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No