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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-22

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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The objective of the study is to:

1. Establish the levels of cytokines in peri-implant crevicular fluid and test the levels of cytokines associated with hypersensitivity (Type 2: Interleukin-4 \[IL-4\], Interleukin-5 \[IL-5\], and Interleukin-13 \[IL-13\]) and bacterial infection (Type 1 and 3: Interleukin-1 alpha \[IL-1α\], Interleukin-2 \[IL-2\], Interleukin-6 \[IL-6\], Interleukin-8 \[IL-8\], Interleukin-10 \[IL-10\], Interleukin-12 \[IL-12\], Interleukin-17 \[IL-17\], Granulocyte-Macrophage Colony-Stimulating Factor \[GM-CSF\], Interferon-gamma \[IFN-γ\], Tumor Necrosis Factor-alpha \[TNF-α\]) between healthy implants and inflamed implants (mucositis and peri-implantitis).
2. Compare the levels of Matrix Metalloproteinases (MMPs: MMP-1, MMP-2, and MMP-9) and Receptor Activator of Nuclear Factor Kappa-Β Ligand (RANKL) associated with tissue destruction and bone loss between healthy and inflamed implants.

Conditions

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Dental Implant Failed Implant Complication Implant Site Infection Implant Site Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Dental implants

Intra-oral photograph

Sample of Peri-implant Crevicular fluid

Clinical Examination

Peri-apical x-ray

Clinical Examination

Intervention Type DIAGNOSTIC_TEST

Clinical examination of a dental implant

Peri-implant crevicular fluid

Intervention Type PROCEDURE

Collection of a sample of peri-implant crevicular fluid

Interventions

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Clinical Examination

Clinical examination of a dental implant

Intervention Type DIAGNOSTIC_TEST

Peri-implant crevicular fluid

Collection of a sample of peri-implant crevicular fluid

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No