Montreal General Hospital - Oral & Maxillofacial Surgery Clinic
Montreal, Quebec, H3G 1A4, Canada
Location status: Recruiting
Recruiting
NCT Number: NCT06515886
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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);
- 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.
Treatment and study plan
clinical examination
Diagnostic TestClinical examination of a dental implant
Peri-implant crevicular fluid
ProcedureCollection of a sample of peri-implant crevicular fluid
Primary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Jul 23, 2024
- Registry last updated
- Jul 23, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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