Clinical trial NCT06515886: Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?
Official title: Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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:

1. 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).
2. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity
timeFrame: September 2022 - December 2024
measure: Levels of cytokines in peri-implant crevicular fluid associated with bacterial infection
timeFrame: September 2022 - December 2024
measure: Levels of Matrix Metalloproteinases in peri-implant crevicular fluid
timeFrame: September 2022 - December 2024
measure: Levels of RANKL in peri-implant crevicular fluid
timeFrame: September 2022 - December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal General Hospital - Oral & Maxillofacial Surgery Clinic
state: Quebec
Study officials:
affiliation: McGill University
name: Heba Allah Madi Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Nicholas Makhoul Dr
role: STUDY_DIRECTOR
affiliation: McGill University
name: Jocelyne Feine Dr
role: STUDY_DIRECTOR
References: