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

NCT06515886 | Recruiting DMC

• 1 other identifier: 20227639
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Levels of cytokines in peri-implant crevicular fluid associated with hypersensitivity

  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.

  September 2022 - December 2024

• Levels of cytokines in peri-implant crevicular fluid associated with bacterial infection

  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.

  September 2022 - December 2024

• Levels of Matrix Metalloproteinases in peri-implant crevicular fluid

  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.

  September 2022 - December 2024

• Levels of RANKL in peri-implant crevicular fluid

  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.

  September 2022 - December 2024

Study Arms (1)

Dental implants

Intra-oral photograph Sample of Peri-implant Crevicular fluid Clinical Examination Peri-apical x-ray

Diagnostic Test: Clinical Examination; Procedure: Peri-implant crevicular fluid

Interventions

Clinical Examination DIAGNOSTIC_TEST

Clinical examination of a dental implant

Dental implants

Peri-implant crevicular fluid PROCEDURE

Collection of a sample of peri-implant crevicular fluid

Dental implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional study is carried out at McGill University Health Center (MUHC)-Montreal General Hospital Oral and Maxillofacial Clinic. The electronic dental records database at the MUHC Montreal General Hospital Oral and Maxillofacial Clinic is screened to identify potentially eligible participants. Individuals who had a functional implant (implant restored with a prosthesis) placed between 2010 and 2022 were reviewed. Eligible individuals are contacted and invited to participate.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital - Oral & Maxillofacial Surgery Clinic

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peri-implant crevicular fluid

MeSH Terms

Conditions

Bacterial Infections; Hypersensitivity; Peri-Implantitis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Immune System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Heba Allah Madi Dr

  McGill University

  PRINCIPAL INVESTIGATOR

• Nicholas Makhoul Dr

  McGill University

  STUDY DIRECTOR

• Jocelyne Feine Dr

  McGill University

  STUDY DIRECTOR

Central Study Contacts

Heba Allah Madi Dr

CONTACT

+14383344777; heba.madi@mail.mcgill.ca

Nicholas Makhoul Dr

CONTACT

+15149341934; nicholas.makhoul@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor and Associate Dean of Post-Graduate Dental Education

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 23, 2024
• Study Start: September 22, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CA (1)