Peri-ImplantitisIDRANCT04888572
Evaluation of the Novel Implant Disease Risk Assessment : a Retrospective Study (IDRA)
An observational study of Peri-Implantitis and Implant Expulsion, run by Saint-Joseph University at 1 site in Lebanon.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Implant Expulsion
- What is being tested?
- Peri-Apical X-ray
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteLebanon
- Study dates
- 11 May 2021to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Peri-Implantitis, Implant Expulsion
- Being tested
- Peri-Apical X-ray
- Keywords
- Risk assessment, Risk factors, IDRA, Risk indicators, Peri-implantitis, Implant loss, Periodontal susceptibility
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-Apical X-rayRadiation
Also called Periodontal Probing
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to thirty minutes
Secondary outcomes (1)
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.
Measured: Up to thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start11 May 2021
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Rbeiz, Saint-Joseph University
- Investigators
- Tamara Rebeiz, DentalSurg, Principal investigator, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888572
- Sponsor's protocol ID
- FMDA5/21
- Acronym
- IDRA
- Status last verified
- Oct 2022
- First submitted
- 9 May 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD that will be collected are confined to the Saint Joseph University's patients and their file are confidential.
Publications
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.
PubMed 32003037Rebeiz 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.
PubMed 38806315
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04888572
- Acronym / sponsor ID
- IDRA / FMDA5/21
- Conditions
- Peri-Implantitis, Implant Expulsion
- Keywords
- Risk assessment, Risk factors, IDRA, Risk indicators, Peri-implantitis, Implant loss, Periodontal susceptibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-Apical X-rayAlso: Periodontal ProbingUsing 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. | Radiation | – |
Primary outcome
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.
1 secondary outcome
Association between IDRA and implant loss
Time frame: Up to thirty minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 32003037Heitz-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.
- Derived from this study: PubMed 38806315Rebeiz 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.
- This website will allow the calculation of the IDRA of each patientLink provided by the sponsor.
- Individual participant dataSharing planned: No. The IPD that will be collected are confined to the Saint Joseph University's patients and their file are confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Rebeiz, DentalSurg principal investigator
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Implant Expulsion, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between IDRA and peri-implantitis (time frame: Up to thirty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888572, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.