Investigating inflammation around dental implants

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

This study is testing the levels of certain substances around dental implants to see what causes inflammation and problems like tissue damage and bone loss.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT06515886 on ClinicalTrials.gov

What this trial studies

This study aims to characterize the inflammation surrounding dental implants by analyzing cytokine levels in peri-implant crevicular fluid. It will compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy and inflamed implants. Additionally, the study will assess the levels of Matrix Metalloproteinases and RANKL to understand tissue destruction and bone loss. The findings could help identify the underlying causes of inflammation in dental implants.

Who should consider this trial

Good fit: Ideal candidates are individuals who have received at least one functional dental implant and have not undergone treatment for peri-implant mucositis or peri-implantitis in the past three months.

Not a fit: Patients with a weak immune system, chronic diseases, or those who have recently received treatment for peri-implant conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients experiencing complications with dental implants.

How similar studies have performed: While there have been studies on peri-implant inflammation, this specific approach of comparing cytokine levels in relation to hypersensitivity and bacterial infection is relatively novel.

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.

Where this trial is running

Montreal, Quebec

• Montreal General Hospital - Oral & Maxillofacial Surgery Clinic — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Heba Allah Madi Dr — McGill University
• Study coordinator: Heba Allah Madi Dr

Conditions: Dental Implant Failed, Implant Complication, Implant Site Infection, Implant Site Reaction, Dental implant, Peri-implant inflammation, Inflammatory mediators, Bacterial infection