Peri-ImplantitisNCT05675241
Characterizing the Inflammation Around Dental Implants
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by McGill University at 1 site in Canada.
Trial summary
The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. 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, Peri-implant Mucositis, Implant Site Reaction
- What is being tested?
- Clinical examination of a dental implant, Radiological Examination and Peri-implant crevicular fluid sample collection
- How many people
- 177 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 1 Dec 2024
- 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: This cross-sectional study is carried out at McGill University Health Center (MUHC) - Montreal General Hospital Oral and Maxillofacial Clinic. The electronic dental records database at the MUHC Montreal General Hospital Oral and Maxillofacial clinic were screened to identify potentially eligible participants. Individuals who had a functional implant (implant restored with a prosthesis) placed between year 2010 and year 2016 were reviewed. Eligible individuals are contacted and invited to participate.
Who may be able to join
- Received at least one functional implant (implant restored with a prothesis);
- Did not receive peri-implant mucositis and peri-implantitis treatment in the past three months.
Who cannot join
- Dental records with incomplete information;
- Individuals with a weak immune system or chronic disease such as diabetes, heart, lung or kidney disease;
- Pregnant women;
- Individuals undergoing orthodontic therapy and those who have oral piercing.
- History of diseases that modify or suppress the immune and inflammatory response, including rheumatoid arthritis, diabetes, lupus, and inflammatory bowel disease and metastatic cancer;
- Taking medications that cause antiresorptive osteonecrosis of the jaw (including any dose of intravenous bisphosphonates, oral bisphosphonate intake for more than three years, receptor activator of nuclear factor kappa-B ligand inhibitors, or antiangiogenic medications);
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- Taking medications known to induce gingival hyperplasia including anticonvulsants, immunosuppressants, or calcium channel blockers;
- Taking steroid medications, systemic or local antibiotics in the last three months (as this may affect the interleukins activity);
- Received radiation therapy to the head and neck or chemotherapy;
- Received treatment to manage an inflamed implant, including management of peri-implantitis and peri-implant mucositis in the last three months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal General Hospital - Oral & Maxillofacial Surgery Clinic
Montreal, Quebec, H3G 1A4
About this study
Official title: Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity, or Both?
The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. The current study will investigate if the inflammation around the implant is due to bacterial infection, hypersensitivity or both.
The goal of this cross-sectional study is to (1) Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection and hypersensitivity reaction; (2) Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis); (3) Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.
Read the detailed description
The main objective of this study is to:
- Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection (Type 1 and 3: IL-1, IL-6, IL-12, IL-17, IL-23, GM-CSF, IFN-γ, TNF-α), hypersensitivity reaction (Type 2: IL-4, IL-5, and IL-13) and the level of MMPs and including MMP-1, MMP-2, MMP-3, MMP-9 and MMP-13.
- Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis).
- Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.
Secondary objectives includes:
- Measure the volume of peri-implant crevicular fluid and compare it between healthy implants and inflamed implants (peri-mucositis and peri-implantitis).
- Investigate the association between the levels of cytokines and the severity of inflammatory responses.
- Show how levels of cytokines influence the severity of inflammatory responses.
- Conditions
- Peri-Implantitis, Peri-implant Mucositis, Implant Site Reaction, Implant Site Infection, Hypersensitivity, Implant Site Rash
- Being tested
- Clinical examination of a dental implant, Radiological Examination, Peri-implant crevicular fluid sample collection
- Keywords
- Peri-implantitis, Peri-implant Mucositis, Hypersensitivity, Dental Implant Failure, Inflammatory Mediators
- Medical subject headings
- Peri-Implantitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination of a dental implantDiagnostic test
Clinical examination includes bleeding on probing, pocket depth, gingival biotype, suppuration, gingival index
Radiological ExaminationDiagnostic test
A standardized periapical radiograph in parallax technique will be taken.
Peri-implant crevicular fluid sample collectionDiagnostic test
A sample of the peri-implant crevicular fluid will be collected using paper strip for 60 seconds. The sample of the fluid will be a resultant of inserting six different strips at the same time in six sites of the implant including mesiobuccal, midbuccal, distobuccal, distopalatal/distolingual, midpalatal/midlingual, mesiopalatal/mesiolingual sites of the implant.
| Study group | Role | What they receive |
|---|---|---|
| Functional Dental Implant | An implant restored with a prothesis and in function for a minimum of one year. Receives: Diagnostic Test: Clinical examination of a dental implant; Diagnostic Test: Radiological Examination; Diagnostic Test: Peri-implant crevicular fluid sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health status of the implant
Classifying the implant into healthy implant, peri-implant mucositis and peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018).
Measured: Baseline (Cross-sectional)
Levels of inflammatory mediators in Periimplant crevicular fluid
Establishing the the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection (Type 1 and 3: IL-1, IL-6, IL-12, IL-17, IL-23, GM-CSF, IFN-γ, TNF-α), hypersensitivity reaction (Type 2: IL-4, IL-5, and IL-13) and the level of MMPs and including MMP-1, MMP-2, MMP-3, MMP-9 and MMP-13.
Measured: Baseline (Cross-sectional)
Secondary outcomes (1)
Gingival Crevicular fluid volume
Measuring the volume of peri-implant crevicular fluid using Periotron device. The measurement unit is μL.
Measured: Baseline (Cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Sep 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cross-sectional
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor
- Investigators
- Heba Allah Madi Dr, Principal investigator, McGill UniversityJocelyne Feine Dr, Study chair, McGill UniversityNicholas Makhoul Dr, Study director, McGill University & McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675241
- Sponsor's protocol ID
- 2022-7639
- Status last verified
- Dec 2022
- First submitted
- 22 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
PubMed 29926491Baseri M, Radmand F, Hamedi R, Yousefi M, Kafil HS. Immunological Aspects of Dental Implant Rejection. Biomed Res Int. 2020 Dec 9;2020:7279509. doi: 10.1155/2020/7279509. eCollection 2020.
PubMed 33376734Annunziato F, Romagnani C, Romagnani S. The 3 major types of innate and adaptive cell-mediated effector immunity. J Allergy Clin Immunol. 2015 Mar;135(3):626-35. doi: 10.1016/j.jaci.2014.11.001. Epub 2014 Dec 18.
PubMed 25528359Poli PP, de Miranda FV, Polo TOB, Santiago Junior JF, Lima Neto TJ, Rios BR, Assuncao WG, Ervolino E, Maiorana C, Faverani LP. Titanium Allergy Caused by Dental Implants: A Systematic Literature Review and Case Report. Materials (Basel). 2021 Sep 12;14(18):5239. doi: 10.3390/ma14185239.
PubMed 34576463Lee CT, Huang YW, Zhu L, Weltman R. Prevalences of peri-implantitis and peri-implant mucositis: systematic review and meta-analysis. J Dent. 2017 Jul;62:1-12. doi: 10.1016/j.jdent.2017.04.011. Epub 2017 May 3.
PubMed 28478213
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity, or Both?
- ClinicalTrials.gov ID
- NCT05675241
- Acronym / sponsor ID
- 2022-7639
- Conditions
- Peri-Implantitis, Peri-implant Mucositis, Implant Site Reaction, Implant Site Infection, Hypersensitivity, Implant Site Rash
- Keywords
- Peri-implantitis, Peri-implant Mucositis, Hypersensitivity, Dental Implant Failure, Inflammatory Mediators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Jan 2023 (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.
The use of titanium dental implants has become a common modern treatment to restore teeth. Although the success rate of dental implants is high, inflammation around the dental implant still occurs. The current study will investigate if the inflammation around the implant is due to bacterial infection, hypersensitivity or both.
The goal of this cross-sectional study is to (1) Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection and hypersensitivity reaction; (2) Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis); (3) Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.
Detailed description
The main objective of this study is to:
- Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection (Type 1 and 3: IL-1, IL-6, IL-12, IL-17, IL-23, GM-CSF, IFN-γ, TNF-α), hypersensitivity reaction (Type 2: IL-4, IL-5, and IL-13) and the level of MMPs and including MMP-1, MMP-2, MMP-3, MMP-9 and MMP-13.
- Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis).
- Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.
Secondary objectives includes:
- Measure the volume of peri-implant crevicular fluid and compare it between healthy implants and inflamed implants (peri-mucositis and peri-implantitis).
- Investigate the association between the levels of cytokines and the severity of inflammatory responses.
- Show how levels of cytokines influence the severity of inflammatory responses.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Dental Implant | – | Diagnostic Test: Clinical examination of a dental implant, Diagnostic Test: Radiological Examination, Diagnostic Test: Peri-implant crevicular fluid sample collectionAn implant restored with a prothesis and in function for a minimum of one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study is carried out at McGill University Health Center (MUHC) - Montreal General Hospital Oral and Maxillofacial Clinic. The electronic dental records database at the MUHC Montreal General Hospital Oral and Maxillofacial clinic were screened to identify potentially eligible participants. Individuals who had a functional implant (implant restored with a prosthesis) placed between year 2010 and year 2016 were reviewed. Eligible individuals are contacted and invited to participate.
Key inclusion criteria (2 listed)
- Received at least one functional implant (implant restored with a prothesis);
- Did not receive peri-implant mucositis and peri-implantitis treatment in the past three months.
Key exclusion criteria (10 listed)
- Dental records with incomplete information;
- Individuals with a weak immune system or chronic disease such as diabetes, heart, lung or kidney disease;
- Pregnant women;
- Individuals undergoing orthodontic therapy and those who have oral piercing.
- History of diseases that modify or suppress the immune and inflammatory response, including rheumatoid arthritis, diabetes, lupus, and inflammatory bowel disease and metastatic cancer;
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 |
|---|---|---|
| Clinical examination of a dental implantClinical examination includes bleeding on probing, pocket depth, gingival biotype, suppuration, gingival index | Diagnostic test | Functional Dental Implant |
| Radiological ExaminationA standardized periapical radiograph in parallax technique will be taken. | Diagnostic test | Functional Dental Implant |
| Peri-implant crevicular fluid sample collectionA sample of the peri-implant crevicular fluid will be collected using paper strip for 60 seconds. The sample of the fluid will be a resultant of inserting six different strips at the same time in six sites of the implant including mesiobuccal, midbuccal, distobuccal, distopalatal/distolingual, midpalatal/midlingual, mesiopalatal/mesiolingual sites of the implant. | Diagnostic test | Functional Dental Implant |
Primary outcome
Health status of the implant
Time frame: Baseline (Cross-sectional)
Classifying the implant into healthy implant, peri-implant mucositis and peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018).
Levels of inflammatory mediators in Periimplant crevicular fluid
Time frame: Baseline (Cross-sectional)
Establishing the the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection (Type 1 and 3: IL-1, IL-6, IL-12, IL-17, IL-23, GM-CSF, IFN-γ, TNF-α), hypersensitivity reaction (Type 2: IL-4, IL-5, and IL-13) and the level of MMPs and including MMP-1, MMP-2, MMP-3, MMP-9 and MMP-13.
1 secondary outcome
Gingival Crevicular fluid volume
Time frame: Baseline (Cross-sectional)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Background: PubMed 29926491Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Background: PubMed 33376734Baseri M, Radmand F, Hamedi R, Yousefi M, Kafil HS. Immunological Aspects of Dental Implant Rejection. Biomed Res Int. 2020 Dec 9;2020:7279509. doi: 10.1155/2020/7279509. eCollection 2020.
- Background: PubMed 25528359Annunziato F, Romagnani C, Romagnani S. The 3 major types of innate and adaptive cell-mediated effector immunity. J Allergy Clin Immunol. 2015 Mar;135(3):626-35. doi: 10.1016/j.jaci.2014.11.001. Epub 2014 Dec 18.
- Background: PubMed 34576463Poli PP, de Miranda FV, Polo TOB, Santiago Junior JF, Lima Neto TJ, Rios BR, Assuncao WG, Ervolino E, Maiorana C, Faverani LP. Titanium Allergy Caused by Dental Implants: A Systematic Literature Review and Case Report. Materials (Basel). 2021 Sep 12;14(18):5239. doi: 10.3390/ma14185239.
- Background: PubMed 28478213Lee CT, Huang YW, Zhu L, Weltman R. Prevalences of peri-implantitis and peri-implant mucositis: systematic review and meta-analysis. J Dent. 2017 Jul;62:1-12. doi: 10.1016/j.jdent.2017.04.011. Epub 2017 May 3.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Heba Allah Madi Dr principal investigator
McGill University
Jocelyne Feine Dr study chair
McGill University
Nicholas Makhoul Dr study director
McGill University & McGill University Health Centre
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 McGill University at 1 site in Canada.
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 2 inclusion and 10 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 9 Jan 2023. 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 Canada. 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?
Health status of the implant (time frame: Baseline (Cross-sectional)). 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 NCT05675241, which also lists 5 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 9 Jan 2023.