Etiology of Early Apical Peri-implantitis

NCT ID: NCT03523845

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-01-31
• Study Completion Date: 2016-12-31

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).

Conditions

Early Apical Peri-implantitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Test group

Test group (patients diagnosed with early apical peri-implantitis diagnosed)

Observational intervention to diagnose an early apical peri-implantitis

Intervention Type: OTHER

diagnose an early apical peri-implantitis

Control group

Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated)

Observational intervention to diagnose an early apical peri-implantitis

Intervention Type: OTHER

diagnose an early apical peri-implantitis

Interventions

Observational intervention to diagnose an early apical peri-implantitis

diagnose an early apical peri-implantitis

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Miguel Peñarrocha Diago

Head of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, Spain.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel Peñarrocha Diago, MD, MDM, PhD

Role: STUDY_CHAIR

Professor and Chairman of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, Spain

Juan Antonio Blaya Tárraga, DDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Master of Oral Surgery and Implantology

References

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.

Reference Type: BACKGROUND

PMID: 12950847 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23278599 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22926472 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26667097 (View on PubMed)

Other Identifiers

LPI1

Identifier Type: -

Identifier Source: org_study_id