Evaluation of the Patient's Risk Profile Using the Peri-implantitis Risk Diagram

NCT05618171 | Completed

• 1 other identifier: 2020/08-03
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Various risk factors defined in the literature should be eliminated in order for the patient to be able to use implant-supported prostheses for a longer period of time. In the literature, such a diagram for peri-implant risk factors was first described by Heitz-Mayfield in 2020. The scheme that will determine the peri-implant risk diagram is called "Implant Disease Risk Assessment (IDRA)". This tool provides evaluation of various risk factors on a single diagram. In this study, peri-implant risk diagrams will be determined by calling the patients who have previously completed implant treatment in Kütahya University of Health Sciences Faculty of Dentistry Department of Periodontology, and the change in the risk profile assessment will be re-evaluated after the risk factors that can be eliminated are eliminated. In this study, it is aimed to predict the risk of inflammation and alveolar bone loss of the tissues around the implant that may occur in the future in patients who have undergone dental implant treatment, and to evaluate the risk profiles.

Conditions

Peri-Implantitis; Peri-implant Mucositis; Dental Implant Failed

Keywords

IDRA; Peri-implantitis

Outcome Measures

Primary Outcomes (2)

• Evaluation of pre- and post-treatment peri-implantitis risk profiles of patients who underwent dental implant treatment at the patient level.

  By using "IDRA", a tool specially developed for patients who have had dental implants in our clinic, patients will be grouped as "low-medium-high" risk according to their initial status in terms of the risk of developing peri-implantitis. Again, these patients will be re-evaluated 1 year after applying Phase I treatment using the "IDRA" tool. Evaluation will be at the patient level.

  1 year after phase 1 treatment

• Evaluation of pre- and post-treatment peri-implantitis risk profiles at implant level in patients who have undergone dental implant treatment.

  By using "IDRA", a tool specially developed for patients who have had dental implants in our clinic, patients will be grouped as "low-medium-high" risk according to their initial status in terms of the risk of developing peri-implantitis. Again, these patients will be re-evaluated 1 year after applying Phase I treatment using the "IDRA" tool. Evaluation will be at the implant level.

  1 year after phase 1 treatment

Interventions

Evaluation of the patient's pre- and post-treatment risk profile using the peri-implantitis risk diagram DIAGNOSTIC_TEST

By using "IDRA", a tool specially developed for patients who have had dental implants in our clinic, patients will be evaluated as "low-moderate-high" risk in terms of the risk of developing peri-implantitis, according to their initial status. Again, these patients will be re-evaluated 1 year after applying Phase I treatment using the "IDRA" tool. During this whole process, clinical and radiographic evaluations will be carried out simultaneously.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent dental implants in Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology

You may qualify if:

• Be over 18
• The condition of making dental implants in Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology
• Finding radiographic documentation of dental implants
• Functioning of the implants in the mouth for at least 1 year

You may not qualify if:

• Antibiotic use in the 3 months before the first examination
• Patients who have not received regular implant maintenance therapy
• Pregnant and breastfeeding women
• Mentally retarded patients

Sponsors & Collaborators

• Berceste Guler: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

Kütahya, 43100, Turkey (Türkiye)

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 RESULT

• Dalago HR, Schuldt Filho G, Rodrigues MA, Renvert S, Bianchini MA. Risk indicators for Peri-implantitis. A cross-sectional study with 916 implants. Clin Oral Implants Res. 2017 Feb;28(2):144-150. doi: 10.1111/clr.12772. Epub 2016 Jan 11.

  PMID: 26754342 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Berceste Güler

  Kütahya Health Sciences University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: December 1, 2020
• Primary Completion: September 5, 2021
• Study Completion: January 28, 2022
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year after the research was published
• Access Criteria: The principal investigator should be contacted.

Locations

TU (1)