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).
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
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis, Dental Implant Failed
- 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
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;
- 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.
- 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.
- 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.
- 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.
- Evaluation of periodontal susceptibility according to the renewed periodontal disease classification by reaching Consensus in 2017
- Evaluation of participation in supportive periodontal therapy. Studies have emphasized the positive effects of patients' regular visits to control appointments.
- 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.
- 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.
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
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.
- First posted16 Nov 2022
- Study start1 Dec 2020
- Primary completion5 Sep 2021
- Study completion28 Jan 2022
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
- Prospective
- Enrolment
- 170 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Berceste Guler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berceste Guler, Kutahya Health Sciences University
- Investigators
- Berceste Güler, Principal investigator, Kütahya Health Sciences University Faculty of Dentistry
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 32003037Dalago 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Patient's Pre- and Post-treatment Risk Profile Using the Peri-implantitis Risk Diagram
- ClinicalTrials.gov ID
- NCT05618171
- Acronym / sponsor ID
- 2020/08-03
- Keywords
- IDRA, Peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Berceste GulerUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 16 Nov 2022 (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.
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.
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;
- 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.
- 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.
- 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.
- 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.
- Evaluation of periodontal susceptibility according to the renewed periodontal disease classification by reaching Consensus in 2017
- Evaluation of participation in supportive periodontal therapy. Studies have emphasized the positive effects of patients' regular visits to control appointments.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent dental implants in Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Evaluation of the patient's pre- and post-treatment risk profile using the peri-implantitis risk diagramBy 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. | Diagnostic test | – |
Primary outcome
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
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.
Evaluation of pre- and post-treatment peri-implantitis risk profiles at implant level in patients who have undergone dental implant treatment.
Time frame: 1 year after phase 1 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: 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.
- Results publication: PubMed 26754342Dalago 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.
- Individual participant dataSharing planned: Yes. It will be shared if the principal investigator is contacted.
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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.
Berceste Güler principal investigator
Kütahya Health Sciences University Faculty of Dentistry
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 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.