Etiology of Early Apical Peri-implantitis (EAP)

• ClinicalTrials.gov Identifier: NCT03523845
• Recruitment Status: Completed
• First Posted: May 14, 2018
• Last Update Posted: May 17, 2018
• Sponsor: University of Valencia
• Information provided by (Responsible Party): Miguel Peñarrocha Diago, University of Valencia

Study Description

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.

Condition or disease	Intervention/treatment
Early Apical Peri-implantitis	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 46 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Target Follow-Up Duration: 1 Year
• Official Title: Etiology of Early Apical Peri-implantitis: A Case-control Study Over a 20-year Period.
• Actual Study Start Date: January 1996
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. type of surgery [ Time Frame: Intraoperative ]
   immediate/delayed placement
2. tooth-implant distance [ Time Frame: Intraoperative ]
   mesial and distal tooth-implant distance measured at the apex
3. Tooth status [ Time Frame: Intraoperative ]
   apical lesion or endodontic treatment in the tooth being replaced or adjacent tooth endodontically treated

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

patients who received at least one dental implant

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.

Contacts and Locations

Sponsors and Collaborators

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

More Information

Additional Information:

Publications of Results:

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.

Peñarrocha-Diago M, Maestre-Ferrín L, Cervera-Ballester J, Peñarrocha-Oltra D. Implant periapical lesion: diagnosis and treatment. Med Oral Patol Oral Cir Bucal. 2012 Nov 1;17(6):e1023-7.

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.

Other Publications:

Quirynen M, Gijbels F, Jacobs R. An infected jawbone site compromising successful osseointegration. Periodontol 2000. 2003;33:129-44. Review.

• Responsible Party: Miguel Peñarrocha Diago, Head of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, Spain., University of Valencia
• ClinicalTrials.gov Identifier: NCT03523845
• Other Study ID Numbers: LPI1
• First Posted: May 14, 2018
• Last Update Posted: May 17, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: higher permissions are needed to make the decision

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Miguel Peñarrocha Diago, University of Valencia:

"early apical peri-implantitis"; "implant periapical lesion"; "retrograde peri-implantitis"; "implant failure"

Additional relevant MeSH terms:

Peri-Implantitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases