Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?

McGill University

Status: Enrolling

Conditions: Dental Implant Failed; Implant Site Reaction; Implant Complication; Implant Site Infection

Treatments: Procedure: Peri-implant crevicular fluid; Diagnostic Test: Clinical Examination

Study type: Observational

Funder types: Other

Identifiers

NCT06515886

20227639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Dental implants

Description:

Intra-oral photograph Sample of Peri-implant Crevicular fluid Clinical Examination Peri-apical x-ray

Treatment:

Diagnostic Test: Clinical Examination

Procedure: Peri-implant crevicular fluid