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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06515886
Enrollment
40
Registered
2024-07-23
Start date
2022-09-22
Completion date
2025-12-01
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIAGNOSTIC_TESTClinical Examination

Clinical examination of a dental implant

PROCEDUREPeri-implant crevicular fluid

Collection of a sample of peri-implant crevicular fluid

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivitySeptember 2022 - December 2024Measure 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 infectionSeptember 2022 - December 2024Measure 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 fluidSeptember 2022 - December 2024Measure 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 fluidSeptember 2022 - December 2024Measure 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.

Countries

Canada

Contacts

Primary ContactHeba Allah Madi Dr
heba.madi@mail.mcgill.ca+14383344777
Backup ContactNicholas Makhoul Dr
nicholas.makhoul@muhc.mcgill.ca+15149341934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026