Actively Recruiting
Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-07-23
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating inflammation around titanium dental implants to understand whether it is caused by bacterial infection, hypersensitivity, or both. This study aims to measure specific immune system proteins called cytokines and other markers in the fluid around dental implants to compare healthy implants with those showing inflammation, such as mucositis or peri-implantitis. The study will also measure proteins linked to tissue damage and bone loss. Participants will undergo clinical examinations including intra-oral photography, peri-apical X-rays, and collection of fluid samples from around their dental implants. The study focuses on analyzing cytokines related to hypersensitivity (like Interleukin-4, -5, and -13) and bacterial infection (such as Interleukin-1 alpha, -2, -6, -8, -10, -12, -17, GM-CSF, IFN-gamma, TNF-alpha). Levels of Matrix Metalloproteinases and RANKL, which are related to tissue destruction and bone loss, will also be compared between healthy and inflamed implants. Participants will provide peri-implant crevicular fluid samples and undergo clinical and radiographic assessments. The study will monitor levels of the cytokines and other markers between September 2022 and December 2024. These measurements will help clarify the causes of inflammation around implants. The research is conducted by McGill University Health Centre and involves adult participants who have received dental implants. The study timeline extends until December 2025.
CONDITIONS
Brief Title
Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity or Both?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received at least one functional implant restored with a prosthesis
- Did not receive treatment for peri-implant mucositis or peri-implantitis in the past three months
- Adults aged 18 years or older
You will not qualify if you...
- Dental records with incomplete information
- Individuals with a weak immune system or chronic diseases such as diabetes, heart, lung, or kidney disease
- Pregnant women
- Individuals undergoing orthodontic therapy or with oral piercings
- History of diseases modifying or suppressing immune and inflammatory response, including rheumatoid arthritis, lupus, inflammatory bowel disease, and metastatic cancer
- Taking medications causing antiresorptive osteonecrosis of the jaw, including intravenous bisphosphonates, long-term oral bisphosphonates, RANKL inhibitors, or antiangiogenic drugs
- Taking medications known to induce gingival hyperplasia such as anticonvulsants, immunosuppressants, or calcium channel blockers
- Recent use of steroid medications, systemic or local antibiotics in the last three months
- Received radiation therapy to head and neck or chemotherapy
- Received treatment for inflamed implants including peri-implantitis or mucositis management in the last three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From September 2022 to December 2024
Participants undergo clinical examination and collection of peri-implant crevicular fluid to assess inflammation and cytokine levels around dental implants.
1 to 2 visits depending on implant condition
Duration - Up to December 2024
Participants are observed for changes in cytokine levels and tissue condition around dental implants over time.
Visits as scheduled during the study period
Trial Site Locations
Total: 1 location
1
Montreal General Hospital - Oral & Maxillofacial Surgery Clinic
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
Research Team
H
Heba Allah Madi Dr
N
Nicholas Makhoul Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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