Clinical trial NCT05675241: Characterizing the Inflammation Around Dental Implants
Official title: Characterizing the Inflammation Around Dental Implants: Bacterial Infection, Hypersensitivity, or Both?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peri-Implantitis
Peri-implant Mucositis
Implant Site Reaction
Implant Site Infection
Hypersensitivity
Implant Site Rash
Implant Infection
Keywords: Peri-implantitis
Peri-implant Mucositis
Hypersensitivity
Dental Implant Failure
Inflammatory Mediators
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2023-01-09
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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 were screened to identify potentially eligible participants. Individuals who had a functional implant (implant restored with a prosthesis) placed between year 2010 and year 2016 were reviewed. Eligible individuals are contacted and invited to participate.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health status of the implant
timeFrame: Baseline (Cross-sectional)
measure: Levels of inflammatory mediators in Periimplant crevicular fluid
timeFrame: Baseline (Cross-sectional)
Secondary outcomes:
measure: Gingival Crevicular fluid volume
timeFrame: Baseline (Cross-sectional)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal General Hospital - Oral & Maxillofacial Surgery Clinic
state: Quebec
Study officials:
affiliation: McGill University
name: Heba Allah Madi Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Jocelyne Feine Dr
role: STUDY_CHAIR
affiliation: McGill University & McGill University Health Centre
name: Nicholas Makhoul Dr
role: STUDY_DIRECTOR
References:
citation: Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
citation: Baseri M, Radmand F, Hamedi R, Yousefi M, Kafil HS. Immunological Aspects of Dental Implant Rejection. Biomed Res Int. 2020 Dec 9;2020:7279509. doi: 10.1155/2020/7279509. eCollection 2020.
citation: Annunziato F, Romagnani C, Romagnani S. The 3 major types of innate and adaptive cell-mediated effector immunity. J Allergy Clin Immunol. 2015 Mar;135(3):626-35. doi: 10.1016/j.jaci.2014.11.001. Epub 2014 Dec 18.
citation: Poli PP, de Miranda FV, Polo TOB, Santiago Junior JF, Lima Neto TJ, Rios BR, Assuncao WG, Ervolino E, Maiorana C, Faverani LP. Titanium Allergy Caused by Dental Implants: A Systematic Literature Review and Case Report. Materials (Basel). 2021 Sep 12;14(18):5239. doi: 10.3390/ma14185239.
citation: Lee CT, Huang YW, Zhu L, Weltman R. Prevalences of peri-implantitis and peri-implant mucositis: systematic review and meta-analysis. J Dent. 2017 Jul;62:1-12. doi: 10.1016/j.jdent.2017.04.011. Epub 2017 May 3.