Evaluation of the Novel Implant Disease Risk Assessment : a Retrospective Study (IDRA) (IDRA)

October 25, 2022 updated by: Tamara Rbeiz, Saint-Joseph University

Assessment of the Association Between the New "Implant Disease Risk Assessment" Tool and Peri-implantitis or Implant Loss: a 5-year Retrospective Cohort Study.

Given the novelty of this risk assessment tool, this study will be interested in evaluating its effectiveness through a retrospective approach. The IDRA risk will be analyzed at the time of loading the implant (s) in patients who have already placed an implant (s) during the last five years at the Department of Periodontology and Oral Surgery using the information collected from the periodontal file previously completed. Therefore, patients whose IDRA has been calculated will be called for a clinical and radiological examination to verify the development or not of peri-implantitis or the loss of the implant. In this way, this tool for predicting peri-implant disease will be evaluated to see if it is really effective.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

First, the files of patients who have placed an implant(s) at the Departments of Periodontology and Oral Surgery of the Faculty of Dental Medicine of Saint Joseph University, Beirut-Lebanon over the past five years (2015, 2016, 2017, 2018 and 2019) will be collected. Subsequently, thanks to the periodontal file and to the X-rays previously taken, the eight periodontal parameters necessary for the determination of the IDRA will be recorded (history of periodontitis; percentage of bleeding on probing; the number of teeth / implants with a pocket depth ≥ 5mm; the ratio between the level of bone loss (evaluated radiographically using retro-alveolar or panoramic X-rays already present in the patient's radiological record on the DBSWIN® software) and the patient's age ( at the time of loading the implant); the susceptibility to periodontitis (diagnosis) as described by the new classification of periodontal diseases and peri-implant from the World Workshop in 2017; compliance with maintenance visits; the distance (in mm) between the limit of the prosthesis and the marginal bone level (seen on the X-ray of the infrastructure or after sealing / screwing the prosthesis); prosthetic factors (such as the precision of adaptation of the prosthesis to the implant or the excess cement) and filled in on an Excel sheet. These data will then be reported online by following this link http://www.ircohe.net/IDRA which will make it possible to calculate by itself the IDRA of each patient.

As a result, each patient will have a personalized IDRA chart and they will be either at low, medium or high risk of developing peri-implantitis.

The retrospective analysis of the files being completed, the patients will be called to come to the Department of Periodontology in order to take the necessary measures to verify the presence or absence of a possible peri-implantitis on the one hand or the loss of the implant on the other hand.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Saint Joseph University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients having placed one or more implants in the Departments of Periodontology or Oral Surgery between 01/01/2015 and 12/31/2019 and whose inclusion criteria are present to allow them to join the study .

Description

Inclusion Criteria:

  1. Adults> 18 years old.
  2. Patients who have placed one or more implants in the last five years at the Departments of Periodontology or Oral Surgery of the FMD and the implants have / have been loaded.
  3. Patients whose periodontal file has been completed and the periodontal parameters required for IDRA reported.
  4. Patients having an x-ray with the loaded implant or an x-ray during the try-in of the infrastructure.

Exclusion Criteria:

  1. Patients with incomplete periodontal charts and missing parameters related to IDRA.
  2. Patients not having an x-ray after loading the implant or during the try-in of the infrastructure
  3. Totally edentulous patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between IDRA and peri-implantitis
Time Frame: Up to thirty minutes
To assess the association between the new risk measurement tool (IDRA) in patients with one or more implants and peri-implantitis Translation results To assess the association between the new risk measurement tool (IDRA) in patients with one or more implants and peri-implantitis.
Up to thirty minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between IDRA and implant loss
Time Frame: Up to thirty minutes
To assess the association between the new risk measurement tool (IDRA) in patients with one or more implants and loss of the implant.
Up to thirty minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Joseph University

Investigators

  • Principal Investigator: Tamara Rebeiz, DentalSurg, Saint-Joseph University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 11, 2021

Primary Completion (ANTICIPATED)

December 20, 2022

Study Completion (ANTICIPATED)

December 20, 2022

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (ACTUAL)

May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMDA5/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD that will be collected are confined to the Saint Joseph University's patients and their file are confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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