NCT05675241

Characterizing the Inflammation Around Dental Implants

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 177 (estimated)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peri-Implantitis
• Peri-implant Mucositis
• Implant Site Reaction
• Implant Site Infection
• Hypersensitivity
• Implant Site Rash
• Implant Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical examination of a dental implant	Clinical examination includes bleeding on probing, pocket depth, gingival biotype, suppuration, gingival index
DIAGNOSTIC_TEST	Radiological Examination	A standardized periapical radiograph in parallax technique will be taken.
DIAGNOSTIC_TEST	Peri-implant crevicular fluid sample collection	A sample of the peri-implant crevicular fluid will be collected using paper strip for 60 seconds. The sample of the fluid will be a resultant of inserting six different strips at the same time in six sites of the implant including mesiobuccal, midbuccal, distobuccal, distopalatal/distolingual, midpalatal/midlingual, mesiopalatal/mesiolingual sites of the implant.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2023-01-09
• Last updated: 2023-01-09

Locations

1 site across 1 country: Canada