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Peri-ImplantitisNCT05618171

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

An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Berceste Guler at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
What is being tested?
Evaluation of the patient's pre- and post-treatment risk profile using the peri-implantitis risk diagram
How many people
170 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2020to 28 Jan 2022
How long will I take part?
1 Year
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 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kütahya Health Sciences University Faculty of Dentistry, Department of Periodontology

    Kütahya, 43100

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Patient's Pre- and Post-treatment Risk Profile Using the Peri-implantitis Risk Diagram

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.

Read the detailed description

Nowadays, dental implants are increasingly applied worldwide for the restoration of lost teeth. It is known that the survival rates of dental implant treatments are quite high, but in recent studies, the maintenance of the health of the peri-implant tissues and the satisfaction of the patient play a more important role in the success of the dental implant, not the survival. 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, a Spider Web scheme named "Perio-tools" has been defined, which evaluates the risk profile of the patient by determining the risk factors for periodontal diseases. However, such a diagram for peri-implant risk factors in the literature 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.

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 using the "IDRA" tool 1 year after applying Phase I treatment. During this whole process, clinical and radiographic evaluations will be carried out simultaneously. Periapical radiographs will be taken from the implant periphery of the patients with the parallel long cone technique. According to the periodontal disease classification made in 2017, the diagnosis of the patients will be evaluated through panoramic radiographs and clinical measurements. Patients will undergo periodontal examination at their first visit. Keratinized gingival width, plaque index, gingival index, attachment loss, bleeding indices on probing will be taken. Peri-implant mucosa will be examined. Peri-implant health status will be recorded according to the following criteria.

The state of being healthy of peri-implant tissues; No bleeding on probing, no swelling, no hyperemia, no signs of inflammation Peri-implant mucositis; Inflammatory lesion limited to the soft tissues surrounding the dental implant and no bone loss Peri-implantitis; Bleeding on probing, presence of bone loss, distance between the most coronal part of the implant in the bone and the bone level ≥ 3mm, pocket depth ≥ 6mm on probing

Plaque index and gingival index are obtained by measuring 4 regions of a tooth (mesial, distal, buccal and lingual) with Williams periodontal probe.

Attachment loss: It is the value of the distance between a tooth and the free gingiva, based on the enamel-cementum junction, measured using a Williams periodontal probe.

Bleeding index in probing: In this index, probing is performed by gently walking around the pocket. As a result of probing, the evaluation is made by looking at the presence or absence of bleeding in the gingiva. If bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and lingual gingival parts of all teeth, a positive value is given. The ratio of the bleeding area to the examined area is expressed as %.

Keratinized gingival width: It is the distance from the free gingival margin to the mucogingival junction line.

Modified plaque index and modified sulcus bleeding index will be used for implants.

Oral hygiene motivation will be given after the periodontal indexes of the patients are recorded.

If the periodontal pocket depth is excessive, routine Phase I treatment will be applied for its elimination. Likewise, risk factors related to prosthetic restoration (occlusal trauma, cement residue) will be eliminated. After all the risk factors that can be eliminated in our clinic have been eliminated, the patient will be called for a repeat risk profile evaluation 1 year later. In the follow-up of the patient 1 year later, clinical and radiographic routine evaluations will be performed again and the results will be compared.

IDRA is a functional risk assessment diagram specially developed for patients with dental implants. Evaluated data;

  1. Evaluation of whether the patient has a history of periodontitis (inflammatory disease of the teeth and surrounding tissues). Studies have shown that patients with a history of periodontitis are at high risk.
  2. Percentage of bleeding in periodontal probing (measurement in the gingival pocket with a periodontal probe). It has been emphasized in studies that as the percentage of bleeding on probing increases, tissue destruction increases and therefore the risk of implant loss increases.
  3. Peri-implant pocket depth ≥5 mm. It is emphasized that the risk of inflammation of the tissues around the tooth and implant increases as the number of teeth or implants with a pocket depth of more than 5 mm increases.
  4. Evaluation of the relationship between age and periodontal bone loss (bone loss/age). Studies emphasize that significant statistical values emerge when bone loss is compared to age.
  5. Evaluation of periodontal susceptibility according to the renewed periodontal disease classification by reaching Consensus in 2017
  6. Evaluation of participation in supportive periodontal therapy. Studies have emphasized the positive effects of patients' regular visits to control appointments.
  7. Evaluation of the relationship between the restoration margin and the bone level. It is emphasized that the risk of inflammation of the tissues around the implant increases as the restoration margin approaches the bone crest.
  8. Factors associated with dental prosthetic restoration (cleanability, evaluation of restoration compliance, etc.). It is emphasized in studies that the risk of implant loss decreases in cases where the prosthetic restorations on the implant are cleanable, well-fitted, screwed or in the absence of excessive cementation.

In this study, it is aimed to predict the risk of future inflammation of peri-implant tissues and alveolar bone loss in patients who have undergone dental implant treatment and to evaluate the risk profiles.

Being tested
Evaluation of the patient's pre- and post-treatment risk profile using the peri-implantitis risk diagram
Keywords
IDRA, Peri-implantitis
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of the patient's pre- and post-treatment risk profile using the peri-implantitis risk diagramDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year after phase 1 treatment

  2. 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.

    Measured: 1 year after phase 1 treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start1 Dec 2020
  3. Primary completion5 Sep 2021
  4. Study completion28 Jan 2022

Resources

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
Prospective
Enrolment
170 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05618171
Sponsor's protocol ID
2020/08-03
Status last verified
Mar 2024
First submitted
8 Nov 2022
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It will be shared if the principal investigator is contacted.

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 32003037
  • 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.

    PubMed 26754342

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Berceste Guler at 1 site in Turkey (Türkiye).

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 4 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: finished, as of the sponsor's last update on 18 Mar 2024. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluation of pre- and post-treatment peri-implantitis risk profiles of patients who underwent dental implant treatment at the patient level. (time frame: 1 year after phase 1 treatment). The study lists 2 primary outcomes in all. 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 NCT05618171, 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 18 Mar 2024.

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