Recruiting

Inflammation Characterization

Sponsor:

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

Code:

NCT06515886

Conditions

Dental Implant Failed

Implant Complication

Implant Site Infection

Implant Site Reaction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Examination

Peri-implant crevicular fluid

Study Details

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.

Conditions

Dental Implant Failed

Implant Complication

Implant Site Infection

Implant Site Reaction

Study ID

NCT06515886

Start date

Sep 22, 2022

Status verified date

Jul, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Dental implants

Intra-oral photograph

Sample of Peri-implant Crevicular fluid

Clinical Examination

Peri-apical x-ray

Interventions

Clinical Examination

Clinical examination of a dental implant

Peri-implant crevicular fluid

Collection of a sample of peri-implant crevicular fluid

Primary outcome measure

  • Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity [ Time Frame: September 2022 - December 2024 ]
  • Levels of cytokines in peri-implant crevicular fluid associated with bacterial infection [ Time Frame: September 2022 - December 2024 ]
  • Levels of Matrix Metalloproteinases in peri-implant crevicular fluid [ Time Frame: September 2022 - December 2024 ]
  • Levels of RANKL in peri-implant crevicular fluid [ Time Frame: September 2022 - December 2024 ]

Central Contacts and Locations

Central contacts

Heba Allah Madi Dr

+14383344777heba.madi@mail.mcgill.ca

Nicholas Makhoul Dr

+15149341934nicholas.makhoul@muhc.mcgill.ca

Locations

Montreal General Hospital - Oral & Maxillofacial Surgery Clinic

Recruiting

Montréal, Quebec, Canada, H3G 1A4

Contacts

Heba Allah Madi Dr

+14383344777heba.madi@mail.mcgill.ca

Principal Investigator:

Heba Allah Madi Dr

More Information

Sponsor

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

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Keywords

  • Dental implant
  • Peri-implant inflammation
  • Inflammatory mediators
  • Bacterial infection
  • Hypersensitivity
  • peri-implantitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-07-23.