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

NCT ID: NCT04888572

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-11

Study Completion Date

2022-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peri-Implantitis Implant Expulsion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Peri-Apical X-ray

Using a PCP UNC 15 Hu Friedy® periodontal probe and a gentle horizontal sweeping motion through the peri-implant "tunnel" or sulcus the examiner will assess bleeding on probing, the main factor in determining peri-implant inflammation and subsequently possible peri-implantitis. Then, using the same instrument, the author will examine whether there is an increase in the values of pocket depths compared to the initial values, highlighting an installation of peri-implant disease. Radiographically, evidence of bone loss after healing through taking a digital x-ray that will be viewed on DBSWIN® software will help authors make a diagnosis of peri-implantitis as well. It will be required that the digital film be perfectly parallel to the axis of the implant and the X-ray tube perpendicular to them in order to have an orthogonal radiograph.

Intervention Type RADIATION

Other Intervention Names

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Periodontal Probing

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Tamara Rbeiz

Doctor of Dental Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamara Rebeiz, DentalSurg

Role: PRINCIPAL_INVESTIGATOR

Saint-Joseph University

Locations

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Saint Joseph University

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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Heitz-Mayfield LJA, Heitz F, Lang NP. Implant Disease Risk Assessment IDRA-a tool for preventing peri-implant disease. Clin Oral Implants Res. 2020 Apr;31(4):397-403. doi: 10.1111/clr.13585. Epub 2020 Feb 20.

Reference Type BACKGROUND
PMID: 32003037 (View on PubMed)

Rebeiz T, Nasr L, Kassir AR, Menassa G, Chakar C. Assessment of the association between the Implant Disease Risk Assessment (IDRA) tool and peri-implantitis: a retrospective cohort study with up to 8 years of follow-up. Int J Oral Maxillofac Surg. 2024 Oct;53(10):845-852. doi: 10.1016/j.ijom.2024.05.002. Epub 2024 May 27.

Reference Type DERIVED
PMID: 38806315 (View on PubMed)

Related Links

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http://www.ircohe.net/IDRA

This website will allow the calculation of the IDRA of each patient

Other Identifiers

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FMDA5/21

Identifier Type: -

Identifier Source: org_study_id

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