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

Peri-Implantitis Clinical Trial

— IDRA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04888572
• Other study ID #: FMDA5/21
• Status: Enrolling by invitation
• Start date: May 11, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2022
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Implant Expulsion
• Peri-Implantitis

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Lebanon	Saint Joseph University	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between IDRA and peri-implantitis	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	Association between IDRA and implant loss	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

External Links

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