Skip to main content
OpenTrials
Completed

NCT Number: NCT03523845

Etiology of Early Apical Peri-implantitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational intervention to diagnose an early apical peri-implantitis

Other

diagnose an early apical peri-implantitis

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Acronym: EAP

Important dates

Study start
1996
Primary completion
2016
Study completion
2016
First posted
May 14, 2018
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.