Characterizing the Inflammation Around Dental Implants

• Conditions: Peri-implant Mucositis; Implant Infection; Implant Site Reaction; Implant Site Rash; Peri-Implantitis; Hypersensitivity; Implant Site Infection
• Interventions: Diagnostic Test: Clinical examination of a dental implant; Diagnostic Test: Radiological Examination; Diagnostic Test: Peri-implant crevicular fluid sample collection

• Registration Number: NCT05675241
• Lead Sponsor: McGill University

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.

The goal of this cross-sectional study is to (1) Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection and hypersensitivity reaction; (2) Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis); (3) Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.

Detailed Description

The main objective of this study is to:

1. Establish the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection (Type 1 and 3: IL-1, IL-6, IL-12, IL-17, IL-23, GM-CSF, IFN-γ, TNF-α), hypersensitivity reaction (Type 2: IL-4, IL-5, and IL-13) and the level of MMPs and including MMP-1, MMP-2, MMP-3, MMP-9 and MMP-13.

2. Compare the levels of cytokines associated with hypersensitivity and bacterial infection between healthy implants and inflamed implants (peri-mucositis and peri-implantitis).

3. Determine whether the difference in the levels of cytokines, if they exist, reflects the clinical diagnosis of healthy implants and inflamed implants.

Secondary objectives includes:

1. Measure the volume of peri-implant crevicular fluid and compare it between healthy implants and inflamed implants (peri-mucositis and peri-implantitis).

2. Investigate the association between the levels of cytokines and the severity of inflammatory responses.

3. Show how levels of cytokines influence the severity of inflammatory responses.

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 177

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
Functional Dental Implant	Peri-implant crevicular fluid sample collection	An implant restored with a prothesis and in function for a minimum of one year.
Functional Dental Implant	Radiological Examination	An implant restored with a prothesis and in function for a minimum of one year.
Functional Dental Implant	Clinical examination of a dental implant	An implant restored with a prothesis and in function for a minimum of one year.

Primary Outcome Measures

Name	Time	Method
Health status of the implant	Baseline (Cross-sectional)	Classifying the implant into healthy implant, peri-implant mucositis and peri-implantitis according to the 2017 World Workshop (Berglundh et al. 2018).
Levels of inflammatory mediators in Periimplant crevicular fluid	Baseline (Cross-sectional)	Establishing the the levels of cytokines in peri-implant crevicular fluid associated with bacterial infection (Type 1 and 3: IL-1, IL-6, IL-12, IL-17, IL-23, GM-CSF, IFN-γ, TNF-α), hypersensitivity reaction (Type 2: IL-4, IL-5, and IL-13) and the level of MMPs and including MMP-1, MMP-2, MMP-3, MMP-9 and MMP-13.

Secondary Outcome Measures

Name	Time	Method
Gingival Crevicular fluid volume	Baseline (Cross-sectional)	Measuring the volume of peri-implant crevicular fluid using Periotron device. The measurement unit is μL.

Trial Locations

Locations (1)

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