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

Recruiting

• Conditions: Implant Complication; Dental Implant Failed; Implant Site Infection; Implant Site Reaction
• Interventions: Diagnostic Test: Clinical Examination; Procedure: Peri-implant crevicular fluid

• Registration Number: NCT06515886
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2022-09-22
• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dental implants	Peri-implant crevicular fluid	Intra-oral photograph Sample of Peri-implant Crevicular fluid Clinical Examination Peri-apical x-ray
Dental implants	Clinical Examination	Intra-oral photograph Sample of Peri-implant Crevicular fluid Clinical Examination Peri-apical x-ray

Primary Outcome Measures

Name	Time	Method
Levels of cytokines in peri-implant crevicular fluid associated with bacterial infection	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 RANKL in peri-implant crevicular fluid	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.
Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity	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 Matrix Metalloproteinases in peri-implant crevicular fluid	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.

Trial Locations

Locations (1)

Montreal General Hospital - Oral & Maxillofacial Surgery Clinic; 🇨🇦 Montréal, Quebec, Canada