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

NCT04888572 | Unknown

• 1 other identifier: FMDA5/21
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-Implantitis; Implant Expulsion

Keywords

Risk assessment; Risk factors; IDRA; Risk indicators; Peri-implantitis; Implant loss; Periodontal susceptibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between IDRA and implant loss

  Up to thirty minutes

Interventions

Peri-Apical X-ray RADIATION

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.

Also known as: Periodontal Probing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• Adults\> 18 years old.
• 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.
• Patients whose periodontal file has been completed and the periodontal parameters required for IDRA reported.
• Patients having an x-ray with the loaded implant or an x-ray during the try-in of the infrastructure.

You may not qualify if:

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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Related Publications (2)

• 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.

  PMID: 32003037 BACKGROUND

• 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.

  PMID: 38806315 DERIVED

Related Links

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

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Tamara Rebeiz, DentalSurg

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 17, 2021
• Study Start: May 11, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)