Dental Implant FailedNCT06515886
Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?
An observational study of Dental Implant Failed and Implant Complication, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 older
- Conditions the study is for
- Dental Implant Failed, Implant Complication, Implant Site Infection
- What is being tested?
- Clinical Examination and Peri-implant crevicular fluid
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2022to 1 Dec 2025
- 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
- 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 is screened to identify potentially eligible participants. Individuals who had a functional implant (implant restored with a prosthesis) placed between 2010 and 2022 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, 1 recruiting
- Recruiting
Montreal General Hospital - Oral & Maxillofacial Surgery Clinic
Montreal, Quebec, H3G 1A4
Heba Allah Madi Dr, +14383344777, heba.madi@mail.mcgill.ca
Heba Allah Madi Dr
About this study
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.
Read the detailed description
The objective of the study is to:
- Establish the levels of cytokines in peri-implant crevicular fluid and test the levels of cytokines associated with hypersensitivity (Type 2: Interleukin-4 [IL-4], Interleukin-5 [IL-5], and Interleukin-13 [IL-13]) and bacterial infection (Type 1 and 3: Interleukin-1 alpha [IL-1α], Interleukin-2 [IL-2], Interleukin-6 [IL-6], Interleukin-8 [IL-8], Interleukin-10 [IL-10], Interleukin-12 [IL-12], Interleukin-17 [IL-17], Granulocyte-Macrophage Colony-Stimulating Factor [GM-CSF], Interferon-gamma [IFN-γ], Tumor Necrosis Factor-alpha [TNF-α]) between healthy implants and inflamed implants (mucositis and peri-implantitis).
- Compare the levels of Matrix Metalloproteinases (MMPs: MMP-1, MMP-2, and MMP-9) and Receptor Activator of Nuclear Factor Kappa-Β Ligand (RANKL) associated with tissue destruction and bone loss between healthy and inflamed implants.
- Conditions
- Dental Implant Failed, Implant Complication, Implant Site Infection, Implant Site Reaction
- Being tested
- Clinical Examination, Peri-implant crevicular fluid
- Keywords
- Dental implant, Peri-implant inflammation, Inflammatory mediators, Bacterial infection, Hypersensitivity, peri-implantitis
- Medical subject headings
- Bacterial Infections, Hypersensitivity, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ExaminationDiagnostic test
Clinical examination of a dental implant
Peri-implant crevicular fluidProcedure or surgery
Collection of a sample of peri-implant crevicular fluid
| Study group | Role | What they receive |
|---|---|---|
| Dental implants | Intra-oral photograph
Sample of Peri-implant Crevicular fluid
Clinical Examination
Peri-apical x-ray Receives: Diagnostic Test: Clinical Examination; Procedure: Peri-implant crevicular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity
Measure the levels of IL-4, IL-5, and IL-13 in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis).
The measured unit is pg/ml.
Measured: September 2022 - December 2024
Levels of cytokines in peri-implant crevicular fluid associated with bacterial infection
Measure the levels of IL-1α, IL-2, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α, GM-CSF, and IFN-γ in the peri-implant crevicular fluid to assess bacterial responses between healthy implants and inflamed implants (mucositis and peri-implantitis).
The measured unit is pg/ml.
Measured: September 2022 - December 2024
Levels of Matrix Metalloproteinases in peri-implant crevicular fluid
Measure the levels of MMP-1, MMP-2, and MMP-9 in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis).
The measured unit is pg/ml.
Measured: September 2022 - December 2024
Levels of RANKL in peri-implant crevicular fluid
Measure the levels of RANKL in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis).
The measured unit is pg/ml.
Measured: September 2022 - December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start22 Sep 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Makhoul, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Heba Allah Madi Dr, Principal investigator, McGill UniversityNicholas Makhoul Dr, Study director, McGill UniversityJocelyne Feine Dr, Study director, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515886
- Sponsor's protocol ID
- 20227639
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. 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
- NCT06515886
- Acronym / sponsor ID
- 20227639
- Conditions
- Dental Implant Failed, Implant Complication, Implant Site Infection, Implant Site Reaction
- Keywords
- Dental implant, Peri-implant inflammation, Inflammatory mediators, Bacterial infection, Hypersensitivity, peri-implantitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
Detailed description
The objective of the study is to:
- Establish the levels of cytokines in peri-implant crevicular fluid and test the levels of cytokines associated with hypersensitivity (Type 2: Interleukin-4 [IL-4], Interleukin-5 [IL-5], and Interleukin-13 [IL-13]) and bacterial infection (Type 1 and 3: Interleukin-1 alpha [IL-1α], Interleukin-2 [IL-2], Interleukin-6 [IL-6], Interleukin-8 [IL-8], Interleukin-10 [IL-10], Interleukin-12 [IL-12], Interleukin-17 [IL-17], Granulocyte-Macrophage Colony-Stimulating Factor [GM-CSF], Interferon-gamma [IFN-γ], Tumor Necrosis Factor-alpha [TNF-α]) between healthy implants and inflamed implants (mucositis and peri-implantitis).
- Compare the levels of Matrix Metalloproteinases (MMPs: MMP-1, MMP-2, and MMP-9) and Receptor Activator of Nuclear Factor Kappa-Β Ligand (RANKL) associated with tissue destruction and bone loss between healthy and inflamed implants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental implants | – | Diagnostic Test: Clinical Examination, Procedure: Peri-implant crevicular fluidIntra-oral photograph Sample of Peri-implant Crevicular fluid Clinical Examination Peri-apical x-ray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 is screened to identify potentially eligible participants. Individuals who had a functional implant (implant restored with a prosthesis) placed between 2010 and 2022 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 ExaminationClinical examination of a dental implant | Diagnostic test | Dental implants |
| Peri-implant crevicular fluidCollection of a sample of peri-implant crevicular fluid | Procedure or surgery | Dental implants |
Primary outcome
Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity
Time frame: September 2022 - December 2024
Measure the levels of IL-4, IL-5, and IL-13 in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis). The measured unit is pg/ml.
Levels of cytokines in peri-implant crevicular fluid associated with bacterial infection
Time frame: September 2022 - December 2024
Measure the levels of IL-1α, IL-2, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α, GM-CSF, and IFN-γ in the peri-implant crevicular fluid to assess bacterial responses between healthy implants and inflamed implants (mucositis and peri-implantitis). The measured unit is pg/ml.
Levels of Matrix Metalloproteinases in peri-implant crevicular fluid
Time frame: September 2022 - December 2024
Measure the levels of MMP-1, MMP-2, and MMP-9 in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis). The measured unit is pg/ml.
Levels of RANKL in peri-implant crevicular fluid
Time frame: September 2022 - December 2024
Measure the levels of RANKL in the peri-implant crevicular fluid to assess hypersensitivity responses between healthy implants and inflamed implants (mucositis and peri-implantitis). The measured unit is pg/ml.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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
Nicholas Makhoul Dr study director
McGill University
Jocelyne Feine Dr study director
McGill 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 Dental Implant Failed and Implant Complication, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 23 Jul 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 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?
Contact Heba Allah Madi Dr (+14383344777, heba.madi@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity (time frame: September 2022 - December 2024). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.